This site was created and maintained by father, Michael, and daughter, Raegan.  Just one year ago Raegan was diagnosed with Type 1 diabetes.  Like most of us, the diagnosis was quite acute. 

Event DateEvent TypeManufacturerBrand NameDevice ProblemPatient ProblemEvent Text
2022/01/22 5:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMInsufficient InformationHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE ROSE TO 26 MMOL/L (468 MG/DL). THE POD WAS WORN ON THE PATIENT'S BACK FOR BETWEEN 1 AND 4 HOURS. AS TREATMENT, A NEW POD WAS APPLIED AND A MANUAL INSULIN INJECTION WAS ADMINISTERED. Manufacturer Narrative: THE EXPOSED PORTION OF THE SOFT CANNULA WAS OBSERVED TO BE KINKED. DURING THE INVESTIGATION, THE KINK DID NOT PREVENT FLUID FROM EXITING THE DISTAL TIP OF THE SOFT CANNULA AND NO SIGNS OF LEAKAGE WERE OBSERVED. INSPECTION OF THE DEVICE DID NOT FIND ANY ISSUES THAT WOULD RESULT IN THE DEVICE FAILING TO DELIVER INSULIN. THE DATA DOWNLOADED FROM THE DEVICE DID NOT SHOW ANY TIMEOUTS OR DRIVE STALLS DURING THE RUN. ALTHOUGH THE CANNULA WAS DAMAGED, THE TIMING AND CAUSE OF THE DAMAGE IS UNKNOWN. NO OTHER DAMAGES OR DEFICIENCIES WERE OBSERVED DURING THE INVESTIGATION. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/01/25 5:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMInsufficient InformationHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVEL REACHED 14 MMOL/L (252 MG/DL). THE POD WAS WORN BETWEEN 4 AND 24 HOURS ON THE ABDOMEN. HYPERGLYCEMIA TREATED WITH A NEW POD AND CORRECTIONAL BOLUS. Manufacturer Narrative: THE EXPOSED PORTION OF THE SOFT CANNULA WAS OBSERVED TO BE FLATTENED. ADDITIONALLY, THE OVERALL LENGTH OF THE SOFT CANNULA MEASURED OUT TO BE 1.081", WHICH IS OUT OF SPECIFICATION. DURING INVESTIGATION, THE DAMAGE OBSERVED ON THE EXPOSED PORTION OF THE SOFT CANNULA DID NOT PREVENT FLUID FROM FLOWING THROUGH THE FLUID PATH AND LEAVING IT VIA THE DISTAL TIP OF THE SOFT CANNULA. THE DOWNLOADED DATA DID NOT SHOW ANY TIMEOUTS OR DRIVE STALLS THAT WOULD INDICATE A FAILURE OF THE DEVICE TO DELIVER INSULIN. ALTHOUGH DAMAGE WAS OBSERVED ON THE EXPOSED PORTION OF THE SOFT CANNULA, THE TIMING AND CAUSE COULD NOT BE DETERMINED. NO OTHER DAMAGES OR ABNORMALITIES WERE OBSERVED THAT WOULD AFFECT INSULIN DELIVERY. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/29 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE (BG) READ "HIGH" (>27.8 MMOL/L) (>500MG/DL) WHILE WEARING THE POD BETWEEN 36 AND 48 HOURS. WHEN REMOVED FROM THE INFUSION SITE (HIP/BUTTOCKS), THE POD'S CANNULA WAS FOUND BENT. AS TREATMENT, A NEW POD WAS APPLIED. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/16 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMFailure to Fire No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED BY THE PATIENT THAT THE CANNULA DID NOT DEPLOY OR INSERT AS INTENDED DURING ACTIVATION. THE PINK SLIDE WAS NOT FORWARD, INDICATING A NEEDLE MECHANISM FAILURE. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/19 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMPremature Activation No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED BY THE PATIENT THAT THEY HAD A POD WHERE THE NEEDLE DEPLOYED EARLY BEFORE THE POD WAS APPLIED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/25 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMPremature Activation No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED BY THE PATIENT THAT THEY HAD A POD WHERE THE NEEDLE DEPLOYED EARLY BEFORE THE POD WAS APPLIED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/03/16 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED OVER 300 MG/DL WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. WHEN REMOVED FROM THE INFUSION SITE (ABDOMEN), THE POD'S CANNULA WAS FOUND BENT. AS TREATMENT, A NEW POD WAS APPLIED. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/29 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 300 MG/DL WHILE WEARING THE POD LESS THAN ONE HOUR. WHEN REMOVED FROM THE INFUSION SITE (HIP/BUTTOCKS), THE POD'S CANNULA WAS FOUND BENT. AS TREATMENT, A MANUAL INJECTION OF INSULIN WAS DELIVERED. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/22 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH, PODS 10-PACKMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT¿S BLOOD GLUCOSE LEVEL WAS "HIGH" (>27.8 MMOL/L,>500 MG/DL) WITH KETONES OF 0.1. THE POD WAS WORN BETWEEN 4 AND 24 HOURS ON THE BACK. IT WAS NOTED THAT THE CANNULA WAS BENT. HYPERGLYCEMIA TREATED WITH A NEW POD AND CORRECTIONAL BOLUS. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/28 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 379 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. WHEN REMOVED FROM THE INFUSION SITE (ARM), THE POD'S CANNULA WAS FOUND BENT. ADDITIONAL METHOD OF TREATMENT WAS NOT PROVIDED. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/25 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN PUMPMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 20.5 MMOL/L (369 MG/DL). THE POD WAS WORN BETWEEN 4 AND 24 HOURS ON THE ABDOMEN. IT WAS NOTED THAT THE CANNULA WAS BENT. HYPERGLYCEMIA TREATED WITH CORRECTIONAL BOLUS AND A NEW POD. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/22 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN PUMPMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT¿S BLOOD GLUCOSE LEVEL WAS "HIGH" (>27.8 MMOL/L,>500 MG/DL) WITH KETONES PRESENT. THE POD WAS WORN BETWEEN 4 AND 24 HOURS ON THE ABDOMEN. IT WAS NOTED THAT THE CANNULA WAS BENT. HYPERGLYCEMIA TREATED WITH A MANUAL INJECTION AND A NEW POD. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/25 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN PUMPMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 17.1 MMOL/L (307.8 MG/DL). THE POD WAS WORN BETWEEN 36 AND 48 HOURS ON THE LEG. IT WAS NOTED THAT THE CANNULA WAS BENT. HYPERGLYCEMIA TREATED WITH A NEW POD. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/25 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMUnintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED OVER 600 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. THE CANNULA DISLODGED FROM THE INFUSION SITE. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/25 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMUnintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED OVER 600 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. THE CANNULA DISLODGED FROM THE INFUSION SITE. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/25 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMUnintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED OVER 600 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. THE CANNULA DISLODGED FROM THE INFUSION SITE. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/25 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMFailure to Fire No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED BY THE PATIENT THAT THE CANNULA DID NOT DEPLOY OR INSERT AS INTENDED DURING ACTIVATION. THE PINK SLIDE WAS NOT FORWARD, INDICATING A NEEDLE MECHANISM FAILURE. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/25 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMFailure to FireHyperglycemiaEvent Description: IT WAS REPORTED BY THE PATIENT THAT THE CANNULA DID NOT DEPLOY OR INSERT AS INTENDED DURING ACTIVATION. THE PINK SLIDE WAS NOT FORWARD, INDICATING A NEEDLE MECHANISM FAILURE. BLOOD GLUCOSE LEVELS REACHED OVER 400 MG/DL. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/25 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMFailure to Fire No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED BY THE PATIENT THAT THE CANNULA DID NOT DEPLOY OR INSERT AS INTENDED DURING ACTIVATION. THE PINK SLIDE WAS NOT FORWARD, INDICATING A NEEDLE MECHANISM FAILURE. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/18 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMUnintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 350 MG/DL WHILE WEARING THE POD BETWEEN 36 AND 48 HOURS. THE CANNULA DISLODGED FROM THE INFUSION SITE (ARM). AS TREATMENT FOR HYPERGLYCEMIA, A MANUAL INJECTION OF INSULIN WAS DELIVERED AND A NEW POD WAS APPLIED. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/25 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMUnintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 279 MG/DL WHILE WEARING THE POD. THE CANNULA DISLODGED FROM THE INFUSION SITE. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/25 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMPremature Activation No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED BY THE PATIENT THAT THEY HAD A POD WHERE THE NEEDLE DEPLOYED EARLY BEFORE THE POD WAS APPLIED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/02/10 5:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMInsufficient InformationHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 395 MG/DL WHILE WEARING THE POD BETWEEN 36 AND 48 HOURS. ON THE LEG. ADDITIONAL METHOD OF TREATMENT WAS NOT PROVIDED. Manufacturer Narrative: THE EXPOSED PORTION OF THE CANNULA WAS OBSERVED TO BE FLATTENED. IT IS UNKNOWN HOW OR WHEN THIS DAMAGE OCCURRED. NO TIMEOUTS OR DRIVE STALLS WERE SEEN IN THE DOWNLOAD DATA THAT WOULD INDICATE A FAILURE TO DELIVER INSULIN. NO OTHER DAMAGES OR DEFECTS WERE FOUND. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/02 5:00:00InjuryINSULET CORPORATIONOMNIPOD INSULIN PUMPInsufficient InformationBacterial Infection; Cellulitis; Skin Inflammation/ IrritationEvent Description: IT WAS REPORTED BY MOTHER THAT THE PATIENT DEVELOPED AN INFECTION AND IRRITATION AT THE POD¿S INSERTION SITE WHILE WEARING THE DEVICE LONGER THAN 48 HOURS ON THE LEG; POD WAS REMOVED 2-3 DAYS PRIOR TO MEDICAL ATTENTION BEING SOUGHT. THE PATIENT WAS TAKEN TO URGENT CARE AND WAS DIAGNOSED WITH CELLULITIS. THE PATIENT WAS PRESCRIBED AUGMENTIN FOR TREATMENT. THIS POD WAS DISCARDED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO CUSTOMER'S INFUSION SITE INFECTION. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2021/07/08 4:00:00InjuryINSULET CORPORATIONOMNIPOD INSULIN PUMPInsufficient InformationBacterial Infection; Cellulitis; Skin Inflammation/ IrritationEvent Description: IT WAS REPORTED BY MOTHER THAT THE PATIENT DEVELOPED AN INFECTION AND IRRITATION AT THE POD¿S INSERTION SITE WHILE WEARING THE DEVICE LONGER THAN 48 HOURS ON THE LEG; POD WAS REMOVED 2-3 DAYS PRIOR TO MEDICAL ATTENTION BEING SOUGHT. THE PATIENT WAS TAKEN TO URGENT CARE AND WAS DIAGNOSED WITH CELLULITIS. THE PATIENT WAS PRESCRIBED BACTRIM FOR TREATMENT. THIS POD WAS DISCARDED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO CUSTOMER'S INFUSION SITE INFECTION. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2021/06/05 4:00:00InjuryINSULET CORPORATIONOMNIPOD INSULIN PUMPInsufficient InformationBacterial Infection; Cellulitis; Skin Inflammation/ IrritationEvent Description: IT WAS REPORTED BY MOTHER THAT THE PATIENT DEVELOPED AN INFECTION AND IRRITATION AT THE POD¿S INSERTION SITE WHILE WEARING THE DEVICE LONGER THAN 48 HOURS ON THE LEG; POD WAS REMOVED 2-3 DAYS PRIOR TO MEDICAL ATTENTION BEING SOUGHT. THE PATIENT WAS TAKEN TO URGENT CARE AND WAS DIAGNOSED WITH CELLULITIS. THE PATIENT WAS PRESCRIBED AUGMENTIN FOR TREATMENT. THIS POD WAS DISCARDED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO CUSTOMER'S INFUSION SITE INFECTION. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/03/26 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 531 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. WHEN REMOVED FROM THE INFUSION SITE (ABDOMEN), THE POD'S CANNULA WAS FOUND BENT. AS TREATMENT, THE PATIENT DRANK WATER AND A CORRECTION WAS GIVEN. THE PATIENT'S BLOOD GLUCOSE, CARBOHYDRATE AND INSULIN HISTORY ARE AS FOLLOWS: (B)(6). Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/28 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN PUMPPremature Activation No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT THE NEEDLE DEPLOYED EARLY WHEN THE POD WAS ACTIVATED; THIS INDICATES A NEEDLE MECHANISM FAILURE OCCURRED. THE POD WAS NOT WORN. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/03/28 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN PUMPPremature Activation No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT THE NEEDLE DEPLOYED EARLY WHEN THE POD WAS ACTIVATED; THIS INDICATES A NEEDLE MECHANISM FAILURE OCCURRED. THE POD WAS NOT WORN. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/03/28 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMFailure to Fire No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT THE CANNULA DID NOT DEPLOY WHEN THE POD WAS ACTIVATED; THIS INDICATES A NEEDLE MECHANISM FAILURE OCCURRED. THE POD WAS WORN FOR LESS THAN ONE HOUR. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/29 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMDifficult to InsertHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 410 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. THE PATIENT REPORTED BEING UNSURE IF THE CANNULA WAS PROPERLY SEATED IN THE INFUSION SITE (ABDOMEN). AS TREATMENT, MORE INSULIN WAS GIVEN. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. IT WAS REPORTED THE CANNULA WAS POSSIBLY NOT INSERTED CORRECTLY INTO THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/28 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMDifficult to InsertHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 320 MG/DL WHILE WEARING THE POD BETWEEN 24 AND 34 HOURS. THE PATIENT REPORTED BEING UNSURE IF THE CANNULA WAS PROPERLY SEATED IN THE INFUSION SITE (ARM). AS TREATMENT, A NEW POD WAS APPLIED AND A CORRECTION WAS GIVEN. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. IT WAS REPORTED THE CANNULA WAS POSSIBLY NOT INSERTED CORRECTLY INTO THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/29 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMRetraction ProblemHyperglycemiaEvent Description: IT WAS REPORTED THAT THE NEEDLE DID NOT RETRACT WHEN THE POD WAS ACTIVATED; THIS INDICATES A NEEDLE MECHANISM FAILURE OCCURRED. THE POD WAS WORN LONGER THAN 48 HOURS AND PATIENT REPORTED A BLOOD GLUCOSE LEVEL OF AROUND 360 MG/DL. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/28 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMFailure to Fire No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT THE CANNULA DID NOT DEPLOY WHEN THE POD WAS ACTIVATED; THIS INDICATES A NEEDLE MECHANISM FAILURE OCCURRED. THE POD WAS WORN FOR LESS THAN ONE HOUR. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/29 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMRetraction Problem No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THE CANNULA RETRACTED, INDICATING A NEEDLE MECHANISM FAILURE. THE PATIENT'S BLOOD GLUCOSE LEVELS WERE NOT AFFECTED. THE POD WAS WORN BETWEEN 1 AND 4 HOURS. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/04 5:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 350 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. WHEN REMOVED FROM THE INFUSION SITE (LEG), THE POD'S CANNULA WAS FOUND BENT. AS TREATMENT, A MANUAL INJECTION OF INSULIN (1U) WAS DELIVERED. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/25 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Unintended MovementHyperglycemia; Skin Inflammation/ IrritationEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) ROSE TO 18.8 MMOL/L (338.4 MG/DL) WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. THE POD REPORTEDLY WAS COMING LOOSE FROM THE INFUSION SITE (ABDOMEN), CAUSING THE CANNULA TO DISLODGE. WHEN REMOVED, THE SITE APPEARED IRRITATED. AS TREATMENT, A NEW POD WAS PLACED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/25 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Unintended MovementHyperglycemia; Skin Inflammation/ IrritationEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) ROSE TO 18.8 MMOL/L (338.4 MG/DL) WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. THE POD REPORTEDLY WAS COMING LOOSE FROM THE INFUSION SITE (ABDOMEN), CAUSING THE CANNULA TO DISLODGE. WHEN REMOVED, THE SITE APPEARED IRRITATED. AS TREATMENT, A NEW POD WAS PLACED. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/25 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Unintended MovementHyperglycemia; Skin Inflammation/ IrritationEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) ROSE TO 18.8 MMOL/L (338.4 MG/DL) WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. THE POD REPORTEDLY WAS COMING LOOSE FROM THE INFUSION SITE (ABDOMEN), CAUSING THE CANNULA TO DISLODGE. WHEN REMOVED, THE SITE APPEARED IRRITATED. AS TREATMENT, A NEW POD WAS PLACED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/25 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Unintended MovementHyperglycemia; Skin Inflammation/ IrritationEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) ROSE TO 18.8 MMOL/L (338.4 MG/DL) WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. THE POD REPORTEDLY WAS COMING LOOSE FROM THE INFUSION SITE (ABDOMEN), CAUSING THE CANNULA TO DISLODGE. WHEN REMOVED, THE SITE APPEARED IRRITATED. AS TREATMENT, A NEW POD WAS PLACED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/25 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Unintended MovementHyperglycemia; Skin Inflammation/ IrritationEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) ROSE TO 18.8 MMOL/L (338.4 MG/DL) WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. THE POD REPORTEDLY WAS COMING LOOSE FROM THE INFUSION SITE (ABDOMEN), CAUSING THE CANNULA TO DISLODGE. WHEN REMOVED, THE SITE APPEARED IRRITATED. AS TREATMENT, A NEW POD WAS PLACED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/25 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Unintended MovementHyperglycemia; Skin Inflammation/ IrritationEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) ROSE TO 18.8 MMOL/L (338.4 MG/DL) WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. THE POD REPORTEDLY WAS COMING LOOSE FROM THE INFUSION SITE (ABDOMEN), CAUSING THE CANNULA TO DISLODGE. WHEN REMOVED, THE SITE APPEARED IRRITATED. AS TREATMENT, A NEW POD WAS PLACED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/25 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Unintended MovementHyperglycemia; Skin Inflammation/ IrritationEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) ROSE TO 18.8 MMOL/L (338.4 MG/DL) WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. THE POD REPORTEDLY WAS COMING LOOSE FROM THE INFUSION SITE (ABDOMEN), CAUSING THE CANNULA TO DISLODGE. WHEN REMOVED, THE SITE APPEARED IRRITATED. AS TREATMENT, A NEW POD WAS PLACED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/25 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Unintended MovementHyperglycemia; Skin Inflammation/ IrritationEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) ROSE TO 18.8 MMOL/L (338.4 MG/DL) WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. THE POD REPORTEDLY WAS COMING LOOSE FROM THE INFUSION SITE (ABDOMEN), CAUSING THE CANNULA TO DISLODGE. WHEN REMOVED, THE SITE APPEARED IRRITATED. AS TREATMENT, A NEW POD WAS PLACED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/25 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Unintended MovementHyperglycemia; Skin Inflammation/ IrritationEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) ROSE TO 18.8 MMOL/L (338.4 MG/DL) WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. THE POD REPORTEDLY WAS COMING LOOSE FROM THE INFUSION SITE (ABDOMEN), CAUSING THE CANNULA TO DISLODGE. WHEN REMOVED, THE SITE APPEARED IRRITATED. AS TREATMENT, A NEW POD WAS PLACED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/25 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Unintended MovementHyperglycemia; Skin Inflammation/ IrritationEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) ROSE TO 18.8 MMOL/L (338.4 MG/DL) WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. THE POD REPORTEDLY WAS COMING LOOSE FROM THE INFUSION SITE (ABDOMEN), CAUSING THE CANNULA TO DISLODGE. WHEN REMOVED, THE SITE APPEARED IRRITATED. AS TREATMENT, A NEW POD WAS PLACED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/25 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Unintended MovementHyperglycemia; Skin Inflammation/ IrritationEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) ROSE TO 18.8 MMOL/L (338.4 MG/DL) WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. THE POD REPORTEDLY WAS COMING LOOSE FROM THE INFUSION SITE (ABDOMEN), CAUSING THE CANNULA TO DISLODGE. WHEN REMOVED, THE SITE APPEARED IRRITATED. AS TREATMENT, A NEW POD WAS PLACED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/25 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Unintended MovementHyperglycemia; Skin Inflammation/ IrritationEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) ROSE TO 18.8 MMOL/L (338.4 MG/DL) WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. THE POD REPORTEDLY WAS COMING LOOSE FROM THE INFUSION SITE (ABDOMEN), CAUSING THE CANNULA TO DISLODGE. WHEN REMOVED, THE SITE APPEARED IRRITATED. AS TREATMENT, A NEW POD WAS PLACED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/25 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Unintended MovementHyperglycemia; Skin Inflammation/ IrritationEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) ROSE TO 18.8 MMOL/L (338.4 MG/DL) WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. THE POD REPORTEDLY WAS COMING LOOSE FROM THE INFUSION SITE, CAUSING THE CANNULA TO DISLODGE. WHEN REMOVED, THE SITE APPEARED IRRITATED. AS TREATMENT, A NEW POD WAS PLACED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/25 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Unintended MovementHyperglycemia; Skin Inflammation/ IrritationEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) ROSE TO 18.8 MMOL/L (338.4 MG/DL) WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. THE POD REPORTEDLY WAS COMING LOOSE FROM THE INFUSION SITE (ABDOMEN), CAUSING THE CANNULA TO DISLODGE. WHEN REMOVED, THE SITE APPEARED IRRITATED. AS TREATMENT, A NEW POD WAS PLACED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/25 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) ROSE TO 18.8 MMOL/L (338.4 MG/DL) WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. THE POD REPORTEDLY WAS COMING LOOSE FROM THE INFUSION SITE (ABDOMEN), CAUSING THE CANNULA TO DISLODGE. WHEN REMOVED, THE SITE APPEARED IRRITATED. AS TREATMENT, A NEW POD WAS PLACED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/13 5:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED OVER 500 MG/DL WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. WHEN REMOVED FROM THE INFUSION SITE, THE POD'S CANNULA WAS FOUND FLAT/BENT. AS TREATMENT FOR HYPERGLYCEMIA, A MANUAL INJECTION OF INSULIN WAS DELIVERED AND A NEW POD WAS APPLIED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/03/25 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Unintended MovementHyperglycemia; Skin Inflammation/ IrritationEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) ROSE TO 18.8 MMOL/L (338.4 MG/DL) WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. THE POD REPORTEDLY WAS COMING LOOSE FROM THE INFUSION SITE (ABDOMEN), CAUSING THE CANNULA TO DISLODGE. WHEN REMOVED, THE SITE APPEARED IRRITATED. AS TREATMENT, A NEW POD WAS PLACED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/22 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN PUMPRetraction Problem Pain; No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT THE NEEDLE DID NOT RETRACT BACK INTO THE POD INDICATING THAT THERE WAS A NEEDLE MECHANISM FAILURE. THE PATIENT DID NOT PROVIDE BLOOD GLUCOSE LEVELS. THE PATIENT ALSO REPORTED PAIN AT THE INFUSION SITE WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. AS TREATMENT THE PATIENT REPLACED THE POD. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/25 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Unintended MovementHyperglycemia; Skin Inflammation/ IrritationEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) ROSE TO 18.8 MMOL/L (338.4 MG/DL) WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. THE POD REPORTEDLY WAS COMING LOOSE FROM THE INFUSION SITE (ABDOMEN), CAUSING THE CANNULA TO DISLODGE. WHEN REMOVED, THE SITE APPEARED IRRITATED. AS TREATMENT, A NEW POD WAS PLACED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/25 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Unintended MovementHyperglycemia; Skin Inflammation/ IrritationEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) ROSE TO 18.8 MMOL/L (338.4 MG/DL) WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. THE POD REPORTEDLY WAS COMING LOOSE FROM THE INFUSION SITE (ABDOMEN), CAUSING THE CANNULA TO DISLODGE. WHEN REMOVED, THE SITE APPEARED IRRITATED. AS TREATMENT, A NEW POD WAS PLACED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/25 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Unintended MovementHyperglycemia; Skin Inflammation/ IrritationEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) ROSE TO 18.8 MMOL/L (338.4 MG/DL) WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. THE POD REPORTEDLY WAS COMING LOOSE FROM THE INFUSION SITE (ABDOMEN), CAUSING THE CANNULA TO DISLODGE. WHEN REMOVED, THE SITE APPEARED IRRITATED. AS TREATMENT, A NEW POD WAS PLACED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/25 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Unintended MovementHyperglycemia; Skin Inflammation/ IrritationEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) ROSE TO 18.8 MMOL/L (338.4 MG/DL) WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. THE POD REPORTEDLY WAS COMING LOOSE FROM THE INFUSION SITE (ABDOMEN), CAUSING THE CANNULA TO DISLODGE. WHEN REMOVED, THE SITE APPEARED IRRITATED. AS TREATMENT, A NEW POD WAS PLACED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/25 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Unintended MovementHyperglycemia; Skin Inflammation/ IrritationEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) ROSE TO 18.8 MMOL/L (338.4 MG/DL) WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. THE POD REPORTEDLY WAS COMING LOOSE FROM THE INFUSION SITE (ABDOMEN), CAUSING THE CANNULA TO DISLODGE. WHEN REMOVED, THE SITE APPEARED IRRITATED. AS TREATMENT, A NEW POD WAS PLACED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/25 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Unintended MovementHyperglycemia; Skin Inflammation/ IrritationEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) ROSE TO 18.8 MMOL/L (338.4 MG/DL) WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. THE POD REPORTEDLY WAS COMING LOOSE FROM THE INFUSION SITE (ABDOMEN), CAUSING THE CANNULA TO DISLODGE. WHEN REMOVED, THE SITE APPEARED IRRITATED. AS TREATMENT, A NEW POD WAS PLACED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/25 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Unintended MovementHyperglycemia; Skin Inflammation/ IrritationEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) ROSE TO 18.8 MMOL/L (338.4 MG/DL) WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. THE POD REPORTEDLY WAS COMING LOOSE FROM THE INFUSION SITE (ABDOMEN), CAUSING THE CANNULA TO DISLODGE. WHEN REMOVED, THE SITE APPEARED IRRITATED. AS TREATMENT, A NEW POD WAS PLACED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/25 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Unintended MovementHyperglycemia; Skin Inflammation/ IrritationEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) ROSE TO 18.8 MMOL/L (338.4 MG/DL) WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. THE POD REPORTEDLY WAS COMING LOOSE FROM THE INFUSION SITE (ABDOMEN), CAUSING THE CANNULA TO DISLODGE. WHEN REMOVED, THE SITE APPEARED IRRITATED. AS TREATMENT, A NEW POD WAS PLACED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/25 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Unintended MovementHyperglycemia; Skin Inflammation/ IrritationEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) ROSE TO 18.8 MMOL/L (338.4 MG/DL) WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. THE POD REPORTEDLY WAS COMING LOOSE FROM THE INFUSION SITE (ABDOMEN), CAUSING THE CANNULA TO DISLODGE. WHEN REMOVED, THE SITE APPEARED IRRITATED. AS TREATMENT, A NEW POD WAS PLACED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/25 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Unintended MovementHyperglycemia; Skin Inflammation/ IrritationEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) ROSE TO 18.8 MMOL/L (338.4 MG/DL) WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. THE POD REPORTEDLY WAS COMING LOOSE FROM THE INFUSION SITE (ABDOMEN), CAUSING THE CANNULA TO DISLODGE. WHEN REMOVED, THE SITE APPEARED IRRITATED. AS TREATMENT, A NEW POD WAS PLACED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/25 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Unintended MovementHyperglycemia; Skin Inflammation/ IrritationEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) ROSE TO 18.8 MMOL/L (338.4 MG/DL) WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. THE POD REPORTEDLY WAS COMING LOOSE FROM THE INFUSION SITE (ABDOMEN), CAUSING THE CANNULA TO DISLODGE. WHEN REMOVED, THE SITE APPEARED IRRITATED. AS TREATMENT, A NEW POD WAS PLACED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/21 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL READ HIGH (>500 MG/DL), AND ALSO HAD KETONE LEVELS UP TO 4.3 MMOL/L (77.4 MG/DL) WHILE WEARING THE POD BETWEEN 1 AND 4 HOURS. WHEN REMOVED FROM THE INFUSION SITE (ABDOMEN), THE POD'S CANNULA WAS FOUND BENT. AS TREATMENT, THE PATIENT GAVE MANUAL INJECTIONS USING AN INSULIN PEN. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/01/02 5:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMFluid LeakHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE ROSE TO 18,6 MMOL/L (334.8 MG/DL). THE POD WAS REPORTEDLY LEAKING WHILE WORN ON THE ABDOMEN FOR BETWEEN 4 AND 24 HOURS. AS TREATMENT, A NEW POD WAS APPLIED AND A BOLUS WAS DELIVERED. Manufacturer Narrative: INVESTIGATION OF THE SOFT CANNULA FOUND IT MEASURED OUT OF SPECIFICATION AT 1.027 INCHES. IT COULD NOT BE DETERMINED WHEN OR HOW THIS DAMAGE OCCURRED. IT COULD NOT BE CONCLUSIVELY DETERMINED IF THIS DAMAGE CONTRIBUTED TO THE REPORTED EVENT. A LEAK TEST PERFORMED ON THE DEVICE FOUND NO OTHER DAMAGES OR DEFICIENCIES ALONG THE COMPLETE FLUID PATH THAT WOULD CAUSE A LEAK TO OCCUR. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/28 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) ROSE TO 22.7 MMOL/L (408.6 MG/DL) WHILE WEARING THE POD BETWEEN 36 AND 48 HOURS. THE POD REPORTEDLY WAS CAME OUT FROM THE INFUSION SITE (ABDOMEN), CAUSING THE CANNULA TO DISLODGE. AS TREATMENT, A NEW POD WAS APPLIED. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/24 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 24 MMOL/L (432 MG/DL) WHILE WEARING THE POD BETWEEN. WHEN REMOVED FROM THE INFUSION SITE (LEG), THE POD'S CANNULA WAS FOUND BENT. AS TREATMENT, A NEW POD WAS PLACED. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/27 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 22.8 MMOL/L (410.4 MG/DL) WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. WHEN REMOVED FROM THE INFUSION SITE (HIP/BUTTOCKS), THE POD'S CANNULA WAS FOUND BENT. AS TREATMENT, A NEW POD WAS PLACED. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/28 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 20 MMOL/L (360 MG/DL) WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. WHEN REMOVED FROM THE INFUSION SITE (LEG), THE POD'S CANNULA WAS FOUND BENT. AS TREATMENT, THE PATIENT GAVE A MANUAL INJECTION USING A SYRINGE. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/28 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEM Activation, Positioning or SeparationProblemHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE (BG) LEVELS ROSE TO 14.9 MMOL/L (268.2 MG/DL) WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. WHEN REMOVED FROM THE INSERTION SITE (ABDOMEN), THE PATIENT NOTICED THAT THE PINK SLIDE DID NOT MOVE FORWARD, INDICATING A NEEDLE MECHANISM FAILURE HAD OCCURRED. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/28 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 26.8 MMOL/L (482.4 MG/DL) WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. WHEN REMOVED FROM THE INFUSION SITE (HIP/BUTTOCKS), THE POD'S CANNULA WAS FOUND BENT. AS TREATMENT, THE PATIENT GAVE A MANUAL INJECTION USING AN INSULIN PEN AND PLACED A NEW POD. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/03/28 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 24 MMOL/L (432 MG/DL) WHILE WEARING THE POD BETWEEN. WHEN REMOVED FROM THE INFUSION SITE (LEG), THE POD'S CANNULA WAS FOUND BENT. AS TREATMENT, A NEW POD WAS PLACED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/23 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 24.4 MMOL/L (439.2 MG/DL) WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. WHEN REMOVED FROM THE INFUSION SITE (HIP/BUTTOCKS), THE POD'S CANNULA WAS FOUND BENT. AS TREATMENT, THE PATIENT GAVE A MANUAL INJECTION USING AN INSULIN PEN AND PLACED A NEW POD. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/03/28 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMFailure to FireHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE (BG) LEVELS ROSE TO 16 MMOL/L (288 MG/DL) WHILE ACTIVATING A NEW POD. THE CANNULA DID NOT DEPLOY AT POD ACTIVATION. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/26 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Material Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 25 MMOL/L (450 MG/DL) WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. THE ADHESIVE WAS NOT SECURED WELL TO THE SKIN. WHEN REMOVED FROM THE INFUSION SITE (ABDOMEN), THE POD'S CANNULA WAS FOUND BENT. AS TREATMENT, A NEW POD AS PLACED AND A BOLUS WAS GIVEN. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/24 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMDifficult to Insert; Material Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 24.5 MMOL/L (441 MG/DL) WHILE WEARING THE POD BETWEEN 1 AND 4 HOURS. THE PATIENT REPORTED BEING UNSURE IF THE CANNULA WAS PROPERLY SEATED IN THE INFUSION SITE AND WAS ALSO BENT. AS TREATMENT, A NEW POD WAS PLACED. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. IT WAS REPORTED THE CANNULA WAS POSSIBLY NOT INSERTED CORRECTLY INTO THE INFUSION SITE AS WELL AS BENT. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/02/14 5:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEM Activation, Positioning or SeparationProblemHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE (BG) LEVELS ROSE TO 23.2 MMOL/L (417.6 MG/DL) WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. WHEN THE POD WAS REMOVED FROM THE INSERTION SITE (ABDOMEN), THE PATIENT NOTICED THAT THE PINK SLIDE DID NOT MOVE FORWARD, INDICATING A NEEDLE MECHANISM FAILURE HAD OCCURRED. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/01 5:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED OVER 300 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. PATIENT STATED THE ADHESIVE WAS LOOSE AND THE CANNULA DISLODGED FROM THE INFUSION SITE (ABDOMEN). AS TREATMENT, A NEW POD WAS APPLIED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/16 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMFailure to Fire No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT THE PATIENT FOUND CANNULA HAD NOT DEPLOYED AS INTENDED. THE CANNULA WAS NOT VISIBLE AND THE PINK SLIDE DID NOT MOVE FORWARD, INDICATING A NEEDLE MECHANISM FAILURE. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/26 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMMaterial Twisted/Bent; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THAT DESPITE DELIVERING CORRECTIONS, THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 290 MG/DL WHILE WEARING THE POD BETWEEN 1 AND 4 HOURS. PATIENT STATED THE CANNULA DISLODGED FROM THE INFUSION SITE (ABDOMEN); UPON REMOVAL, THE CANNULA ALSO APPEARED BENT. AS TREATMENT, A NEW POD WAS APPLIED AND THIS POD WAS DISCARDED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. WE ARE ALSO UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS. ADDITIONALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/22 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMMaterial Twisted/Bent; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED OVER 400 MG/DL WHILE WEARING THE POD. PATIENT STATED THE CANNULA DISLODGED FROM THE INFUSION SITE (ARM); UPON REMOVAL, THE CANNULA ALSO APPEARED BENT. MODERATE KETONES WERE PRESENT AS WELL. AS TREATMENT, A MANUAL INJECTION (10-12 UNITS) WAS DELIVERED AND A NEW POD WAS APPLIED. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. WE ARE ALSO UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS. ADDITIONALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/29 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THAT A PATIENT'S BLOOD GLUCOSE LEVELS (BG) REACHED 300 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. THE PATIENT REPORTED CANNULA BEING DISLODGED, WHILE WEARING IT ON THE LEG. FOR TREATMENT, THE PATIENT CHANGED OUT THE POD FOR A NEW POD. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/29 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMFailure to Fire No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT THE PATIENT FOUND CANNULA HAD NOT DEPLOYED AS INTENDED. THE CANNULA WAS NOT VISIBLE, INDICATING A NEEDLE MECHANISM FAILURE. THE PATIENT'S BLOOD GLUCOSE (BG) VALUES REACHED 208 MG/DL. THE POD WAS DISCARDED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/29 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMPremature Activation No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT THE NEEDLE MECHANISM HAD FULLY DEPLOYED BEFORE THE POD WAS ABLE TO BE USED. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/29 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Fluid Leak; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THAT A PATIENT'S BLOOD GLUCOSE LEVELS (BG) REACHED 300 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. THE PATIENT REPORTED CANNULA BEING DISLODGED, WHILE WEARING IT ON THE ARM. FOR TREATMENT, THE PATIENT CHANGED OUT THE POD AND GAVE CORRECTION BOLUS. THE POD WAS LEAKING. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/22 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMDifficult to Insert; Material Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT A PATIENT'S BLOOD GLUCOSE LEVELS (BG) REACHED ALMOST 300 MG/DL. THE PATIENT REPORTED BEING UNSURE IF THE CANNULA WAS PROPERLY SEATED WHILE WEARING IT ON UNKNOWN LOCATION. THE CANNULA WAS BENT. FOR TREATMENT, THE PATIENT CHANGED OUT THE POD FOR A NEW POD. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. IT WAS REPORTED THE CANNULA WAS POSSIBLY NOT INSERTED CORRECTLY AND BENT INTO THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/29 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Material Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT A PATIENT'S BLOOD GLUCOSE LEVELS (BG) REACHED OVER 250 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. THE PATIENT REPORTED CANNULA BEING BENT WHILE WEARING IT ON THE ARM. FOR TREATMENT, THE PATIENT CHANGED OUT THE POD FOR A NEW POD. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/29 4:00:00InjuryINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMAdverse Event Without Identified Device or Use ProblemLoss of consciousnessEvent Description: IT WAS REPORTED THAT THE PATIENT HAD LOW BLOOD GLUCOSE (BG) VALUES AND WAS TAKEN TO THE EMERGENCY ROOM (ER) BY AMBULANCE. THE PATIENT WAS UNRESPONSIVE AND WAS NOT ABLE TO WALK. FOR TREATMENT, THE PATIENT WAS GIVEN GLUCOSE AND SODA. THE POD WAS WORN LONGER THAN 48 HOURS ON UNKNOWN LOCATION. THE POD WAS DISCARDED AND THE PATIENT WAS DISCHARGED ON THE SAME DAY. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED HOSPITALIZATION. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/26 4:00:00InjuryINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEM Activation, Positioning or SeparationProblem; Material Twisted/BentDehydration; Hyperglycemia; Vomiting; Diabetic KetoacidosisEvent Description: IT WAS REPORTED THAT THE PATIENT WAS TAKEN TO A CHILD URGENT CARE AND WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS (DKA). THE PATIENT'S BLOOD GLUCOSE (BG) VALUES REACHED 355 MG/DL. THE PATIENT WAS VOMITING, DEHYDRATED, HAD HIGH KETONES AND WAS LETHARGIC. FOR TREATMENT, THE PATIENT WAS PUT ON A INTRAVENOUS (IV) OF FLUIDS AND TAKEN TO THE HOSPITAL BY AMBULANCE. AT THE HOSPITAL, THE PATIENT WAS TRANSFERRED TO INTENSIVE CARE UNIT (ICU) AND WAS GIVEN MORE IV'S WITH INSULIN. THE GRANDPARENT REPORTED THAT THE PINK SLIDE INSERT DID NOT MOVE INTO THE VIEWING WINDOW, WHICH INDICATES A FAILURE OF THE NEEDLE MECHANISM TO DEPLOY AS INTENDED DURING ACTIVATION. THE CANNULA WAS BENT, WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS ON THE ARM. THE PATIENT IS STILL IN THE HOSPITAL. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED HOSPITALIZATION AND DIABETIC KETOACIDOSIS. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE AND BENT CANNULA OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/29 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT A PATIENT'S BLOOD GLUCOSE LEVELS (BG) REACHED 425 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. THE PATIENT REPORTED CANNULA BEING BENT WHILE WEARING IT ON THE LEG. FOR TREATMENT, MANUAL INJECTION WAS ADMINISTERED. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/23 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMFailure to Fire No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT THE PATIENT FOUND CANNULA HAD NOT DEPLOYED AS INTENDED. THE CANNULA WAS NOT VISIBLE AND THE PINK SLIDE DID NOT MOVE FORWARD, INDICATING A NEEDLE MECHANISM FAILURE. THE POD WAS DISCARDED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/30 4:00:00InjuryINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMAdverse Event Without Identified Device or Use ProblemHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT WENT TO THE EMERGENCY ROOM (ER) AND WAS DIAGNOSED WITH BLOOD GLUCOSE (BG) VALUES REACHED OVER 400 MG/DL. FOR TREATMENT, THE PATIENT WAS GIVEN INTRAVENOUS (IV) OF UNKNOWN MEDICATION. THE POD WAS WORN BETWEEN 4 AND 24 HOURS ON THE ARM. THE PATIENT IS STILL AT THE HOSPITAL. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED HOSPITALIZATION AND HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS. HIGH BLOOD GLUCOSE IS A COMMON SYMPTOM FOR PEOPLE WITH DIABETES (GLUCOSE MONITORING DATA FROM PEOPLE WITH DIABETES INDICATE THAT ON AVERAGE, THEY CAN EXPERIENCE BLOOD GLUCOSE LEVELS ABOVE 250 MG/DL FOR 14-25% OF THE TIME[1][2][3]..), AND IT WOULD BE CHALLENGING TO SPECULATE ON A CAUSE FOR THE COMPLAINTS WITHOUT RECEIVING THE DEVICES BACK FOR AN ENGINEERING INVESTIGATION. [1] BECK RW, BERGENSTAL RM, CHENG P, KOLLMAN C, CARLSON AL, JOHNSON ML, RODBARD D. THE RELATIONSHIPS BETWEEN TIME IN RANGE, HYPERGLYCEMIA METRICS, AND HBA1C. J DIABETES SCI TECHNOL 2019;13:614-626 [1] WELSH JB, DERDZINSKI M, PARKER AS, PUHR S, JIMENEZ A, WALKER T. REAL-TIME SHARING AND FOLLOWING OF CONTINUOUS GLUCOSE MONITORING DATA IN YOUTH. DIABETES THER 2019;10:751-755 [1] PUHR S, DERDZINSKI M, WELSH JB, PARKER AS, WALKER T, PRICE DA. REAL-WORLD HYPOGLYCEMIA AVOIDANCE WITH A CONTINUOUS GLUCOSE MONITORING SYSTEM'S PREDICTIVE LOW GLUCOSE ALERT. DIABETES TECHNOL THER 2019;21:155-158.
2022/03/26 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM Activation, Positioning or SeparationProblem; Material Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT¿S BLOOD GLUCOSE (BG) LEVEL REACHED BETWEEN 300 MG/DL AND 400 MG/DL WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS ON THE ABDOMEN. PATIENT STATED THE ADHESIVE WAS NOT SECURE. AFTER REALIZING ELEVATED BG LEVELS, PATIENT FOUND THE PINK SLIDE DID NOT MOVE FORWARD AS INTENDED; THIS INDICATES THAT A NEEDLE MECHANISM FAILURE OCCURRED. ADDITIONALLY, CANNULA DEPLOYED BUT WAS FOUND BENT UPON POD REMOVAL. AS TREATMENT, A NEW POD WAS APPLIED AND A CORRECTION WAS DELIVERED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. WE ARE ALSO UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY. ADDITIONALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/24 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM Activation, Positioning or SeparationProblem; Material Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT¿S BLOOD GLUCOSE (BG) LEVEL REACHED UP TO 500 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS ON THE ARM. PATIENT STATED THE ADHESIVE WAS NOT SECURE. AFTER REALIZING ELEVATED BG LEVELS, PATIENT FOUND THE PINK SLIDE DID NOT MOVE FORWARD AS INTENDED; THIS INDICATES THAT A NEEDLE MECHANISM FAILURE OCCURRED. ADDITIONALLY, CANNULA DEPLOYED BUT WAS FOUND BENT UPON POD REMOVAL. AS TREATMENT, A NEW POD WAS APPLIED AND A CORRECTION WAS DELIVERED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. WE ARE ALSO UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY. ADDITIONALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/24 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMPremature Activation No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT THE NEEDLE MECHANISM HAD FULLY DEPLOYED BEFORE THE POD WAS ABLE TO BE USED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2021/10/18 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEM Activation, Positioning or SeparationProblemHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT¿S BLOOD GLUCOSE (BG) REACHED AROUND 300 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS ON THE ABDOMEN. IT WAS DISCOVERED THAT THE PINK SLIDE INSERT DID NOT MOVE INTO THE VIEWING WINDOW, WHICH INDICATES A FAILURE OF THE NEEDLE MECHANISM TO DEPLOY AS INTENDED DURING ACTIVATION. AS TREATMENT, THE PATIENT GAVE CORRECTION BOLUSES. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/27 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT A PATIENT'S BLOOD GLUCOSE LEVELS (BG) REACHED AROUND 320 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. THE PATIENT REPORTED CANNULA BEING BENT WHILE WEARING IT ON THE ABDOMEN. FOR TREATMENT, THE PARENT CHANGED OUT THE POD AND GAVE A MANUAL INJECTION. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/25 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM Activation, Positioning or SeparationProblem No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT THE PINK SLIDE INSERT DID NOT MOVE INTO THE VIEWING WINDOW, WHICH INDICATES A FAILURE OF THE NEEDLE MECHANISM TO DEPLOY AS INTENDED DURING ACTIVATION. AS TREATMENT, THE PATIENT CHANGED OUT THE POD. THE PATIENT'S BLOOD GLUCOSE (BG) VALUES REACHED 189 MG/DL. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/25 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM Activation, Positioning or SeparationProblem No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT THE PINK SLIDE INSERT DID NOT MOVE INTO THE VIEWING WINDOW, WHICH INDICATES A FAILURE OF THE NEEDLE MECHANISM TO DEPLOY AS INTENDED DURING ACTIVATION. AS TREATMENT, THE PATIENT CHANGED OUT THE POD. THE PATIENT'S BLOOD GLUCOSE (BG) VALUES REACHED 189 MG/DL. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/24 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT A PATIENT'S BLOOD GLUCOSE LEVELS (BG) REACHED 370 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. THE PATIENT REPORTED CANNULA BEING BENT WHILE WEARING IT ON THE LEG. FOR TREATMENT, THE PATIENT CHANGED OUT THE POD FOR A NEW POD. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/23 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THAT A PATIENT'S BLOOD GLUCOSE LEVELS (BG) REACHED OVER 400 MG/DL WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. THE PATIENT REPORTED CANNULA BEING DISLODGED, WHILE WEARING IT ON THE LEG. FOR TREATMENT, THE PATIENT CHANGED OUT THE POD FOR A NEW POD. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/24 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMPremature Activation No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT THE NEEDLE MECHANISM HAD FULLY DEPLOYED BEFORE THE POD WAS ABLE TO BE USED. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/25 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT A PATIENT'S BLOOD GLUCOSE LEVELS (BG) REACHED 350 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. THE PATIENT REPORTED CANNULA BEING BENT WHILE WEARING IT ON THE LEG. FOR TREATMENT, MANUAL INJECTION WAS ADMINISTERED. THE KETONES WERE MODERATE. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/24 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMPremature ActivationHyperglycemiaEvent Description: IT WAS REPORTED THAT THE NEEDLE MECHANISM HAD FULLY DEPLOYED BEFORE THE POD WAS ABLE TO BE USED. THE PATIENT'S BLOOD GLUCOSE (BG) VALUES REACHED OVER 300 MG/DL. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/24 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMPremature Activation No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT THE NEEDLE MECHANISM HAD FULLY DEPLOYED BEFORE THE POD WAS ABLE TO BE USED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/22 4:00:00InjuryINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMAdverse Event Without Identified Device or Use ProblemHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT WENT TO THE HOSPITAL AND WAS DIAGNOSED WITH BLOOD GLUCOSE (BG) VALUES THAT REACHED OVER 500 MG/DL. FOR TREATMENT, THE PATIENT WAS GIVEN A INTRAVENOUS (IV) OF SALINE AND INSULIN. THE POD WAS WORN LONGER THAN 48 HOURS ON THE LEG. THE PATIENT WAS DISCHARGED AFTER 4 DAYS. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED HOSPITALIZATION AND HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/25 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT A PATIENT'S BLOOD GLUCOSE LEVELS (BG) REACHED OVER 400 MG/DL WHILE WEARING THE POD BETWEEN 36 AND 48 HOURS. THE PATIENT REPORTED CANNULA BEING BENT WHILE WEARING IT ON THE HIPS/BUTTOCKS. FOR TREATMENT, THE PATIENT CHANGED OUT THE POD AND GAVE A MANUAL INJECTION. THE KETONES WERE LARGE. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/26 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 400 MG/DL WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. WHEN REMOVED FROM THE INFUSION SITE (ARM), THE POD'S CANNULA WAS FOUND BENT. AS TREATMENT FOR HYPERGLYCEMIA, A BOLUS INJECTION OF INSULIN WAS DELIVERED AND A NEW POD WAS APPLIED. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/02/14 5:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMFluid LeakHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 290 MG/DL WHILE WEARING THE POD. Manufacturer Narrative: INSPECTION OF THE CANNULA ASSEMBLY FOUND NO PROBLEMS WITH FLUID PASSING FREELY THROUGH THE COMPLETE FLUID PATH, THOUGH THE EXPOSED PORTION OF THE SOFT CANNULA WAS KINKED. IT COULD NOT BE DETERMINED WHEN THIS DAMAGE OCCURRED. THE DOWNLOAD DATA DOES NOT CONTAIN ANY TIMEOUTS OR PULSE WIDTH INCREASES THAT WOULD INDICATE A FAILURE TO DELIVER INSULIN. NO OTHER DAMAGES OR MANUFACTURING DEFICIENCIES WERE FOUND THAT WOULD RESULT IN THE DEVICE FAILING TO DELIVER INSULIN. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/19 4:00:00InjuryINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMInsufficient InformationSkin Inflammation/ IrritationEvent Description: SKIN IRRITATION CAUSING ITCHING AND REDNESS WAS REPORTED. SYMPTOMS BEGAN 1 HOUR INTO USAGE. THE AFFECTED AREA WAS LOCATED ON THE APPLICATION SITE AND WAS THE SIZE OF THE POD. PATIENT VISITED PHYSICIAN AND WAS PRESCRIBED A CREAM CALLED CLOBETASOL PROPIONATE AND WAS DIRECTED TO APPLY WHEN THE POD IS REMOVED AND AS NEEDED BASED ON BURNING/ITCHING SENSATION. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE SKIN IRRITATION LEADING TO A PRESCRIPTION. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/03/22 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS EXCEEDED 300 MG/DL WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. WHEN REMOVED FROM THE INFUSION SITE (ABDOMEN), THE POD'S CANNULA WAS FOUND BENT. AS TREATMENT FOR HYPERGLYCEMIA, MANUAL INJECTIONS OF INSULIN WAS DELIVERED AND A NEW POD WAS APPLIED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2021/08/05 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 300 MG/DL WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. WHEN REMOVED FROM THE INFUSION SITE (LEG), THE POD'S CANNULA WAS FOUND BENT. AS TREATMENT FOR HYPERGLYCEMIA, A NEW POD WAS APPLIED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/26 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 346 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. WHEN REMOVED FROM THE INFUSION SITE (ARM), THE POD'S CANNULA WAS FOUND BENT. AS TREATMENT FOR HYPERGLYCEMIA, A MANUAL INJECTION OF INSULIN WAS DELIVERED AND A NEW POD WAS APPLIED. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/16 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMDifficult to InsertHyperglycemiaEvent Description: IT WAS REPORTED THAT A PATIENT'S BLOOD GLUCOSE (BG) LEVELS REACHED 400 MG/DL WHILE WEARING THE POD BETWEEN 1 AND 4 HOURS. DUE TO ELEVATED BG LEVELS, PATIENT WAS UNSURE IF THE CANNULA WAS PROPERLY SEATED IN THE INFUSION SITE (ARM). AS TREATMENT FOR HYPERGLYCEMIA, INSULIN WAS DELIVERED AND WATER WAS CONSUMED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THE CANNULA WAS POSSIBLY NOT INSERTED CORRECTLY INTO THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2021/09/26 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMFluid LeakHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVEL REACHED 463 MG/DL AND THAT THERE WAS INSULIN LEAKING AT THE SITE. THE POD WAS WORN BETWEEN 4 AND 24 HOURS ON THE HIP/BUTTOCKS. NO INFORMATION WAS PROVIDED ON HOW THE HYPERGLYCEMIA WAS TREATED. Manufacturer Narrative: THE RECEIVED DEVICE HAD THE CANNULA ASSEMBLY FULLY DEPLOYED. THE LENGTH OF SOFT CANNULA WAS OBSERVED TO BE WITHIN SPECIFICATION. THE EXPOSED PORTION OF THE SOFT CANNULA WAS FOUND TORN, ALLOWING FOR FLUID TO EXIT THROUGH THE TEAR. IT COULD NOT BE CONCLUSIVELY DETERMINED WHEN THIS DAMAGE OCCURRED. THE DOWNLOAD DATA GENERATED AN 0X6A ALARM INDICATING OCCLUSION DURING RUNTIME. NO TIME OUTS OR DRIVE STALLS WERE SEEN IN THE DATA. INSPECTION OF THE DRIVE MECHANISM FOUND NO ISSUES. ALTHOUGH, AN OCCLUSION ALARM WAS GENERATED, THE CAUSE OF THE ALARM COULD NOT BE DETERMINED. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/01/20 5:00:00InjuryINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMInsufficient InformationPurulent Discharge; Skin Inflammation/ Irritation; Swelling/ EdemaEvent Description: IT WAS REPORTED THAT A SKIN IRRITATION CAUSING PAIN, SWELLING AND LIQUID DRAINAGE HAD OCCURRED WHILE WEARING THE POD ON THE ARM. THE PATIENT CONSULTED A DOCTOR AND WAS PRESCRIBED BACTROBAN ANTIBIOTIC OINTMENT FOR TREATMENT. Manufacturer Narrative: WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE SKIN IRRITATION. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/01/29 5:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMInsufficient InformationHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVEL REACHED 16.8 MMOL/L (302.4 MG/DL) AND THAT THE ADHESIVE PAD WAS FULL OF BLOOD. THE POD WAS WORN BETWEEN 4 AND 24 HOURS ON THE LEG. HYPERGLYCEMIA TREATED WITH A NEW POD. Manufacturer Narrative: THE POD WAS RECEIVED WITH EVIDENCE OF BLOOD ON THE ADHESIVE PAD. INVESTIGATION RESULTS FOUND NO EVIDENCE OF ANY DAMAGE OR MANUFACTURING DEFICIENCIES THAT WOULD CAUSE BLEEDING OR BRUISING AT THE INFUSION SITE. THE EXACT CAUSE OF THE REPORTED BLEEDING AND BRUISING COULD NOT BE DETERMINED. A TEAR WAS OBSERVED ON THE EXPOSED PORTION OF THE SOFT CANNULA, CAUSING FLUID TO LEAK FROM IT. WHEN THIS DAMAGE OCCURRED COULD NOT BE DETERMINED. THE EXACT CAUSE OF THIS DAMAGE COULD NOT BE DETERMINED. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/01/16 5:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMFluid LeakHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENTS BLOOD GLUCOSE LEVEL ROSE TO 252 MG/DL. THE POD REPORTEDLY WAS LEAKING INSULIN DURING WEAR WHILE WORN ON THE ARM FOR LONGER THAN 48 HOURS. HYPERGLYCEMIA TREATED WITH A NEW POD. Manufacturer Narrative: THE RETURNED DEVICE WAS EVALUATED AND AN EXTERNAL TEAR WAS FOUND ON THE EXPOSED PORTION OF THE SOFT CANNULA. THE DOWNLOAD DATA CONTAINS NOT TIMEOUTS, DRIVE STALLS, OR HAZARD ALARMS, INDICATING THERE WAS NO STRUGGLE IN DELIVERING INSULIN. IT COULD NOT BE DETERMINED WHEN AND HOW THE CANNULA WAS DAMAGED. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/01/24 5:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMInsufficient InformationHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVEL REACHED 20 MMOL/L (360 MG/DL). THE POD WAS WORN BETWEEN 24 AND 36 HOURS ON THE LEG. HYPERGLYCEMIA TREATED WITH A NEW POD AND CORRECTIONAL BOLUS. Manufacturer Narrative: THE RETURNED DEVICE WAS EVALUATED AND THE SOFT CANNULA WAS FOUND TO BE DAMAGED AND BELOW THE SPECIFICATION LIMIT. THE DOWNLOAD DATA CONTAINS NO TIMEOUTS, DRIVE STALLS, OR HAZARD ALARMS, INDICATING THERE WAS NO STRUGGLE IN DELIVERING INSULIN. IT COULD NOT BE DETERMINED WHEN AND HOW THE CANNULA WAS DAMAGED. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/01/24 5:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMInsufficient InformationHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVEL REACHED 21.8 MMOL/L (392.4 MG/DL). THE POD WAS WORN BETWEEN 4 AND 24 HOURS ON THE HIP/BUTTOCKS. HYPERGLYCEMIA TREATED WITH CORRECTIONAL BOLUS AND A NEW POD. Manufacturer Narrative: THE RETURNED DEVICE WAS EVALUATED AND THE EXPOSED PORTION OF THE SOFT CANNULA WAS FOUND TO BE DAMAGED. THE DOWNLOAD DATA DID NOT SHOW ANY TIMEOUTS OR DRIVE STALLS DURING THE RUN THAT WOULD INDICATE A FAILURE OF THE POD TO DELIVER INSULIN. ALTHOUGH THE CANNULA WAS DAMAGED, THE TIMING AND CAUSE OF THE DAMAGE IS UNKNOWN. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/01/18 5:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMFluid LeakHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENTS BLOOD GLUCOSE LEVEL ROSE TO 20 MMOL/L (360 MG/DL)MG/DL WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS ON THE ARM. IT WAS REPORTED THAT THERE WAS INSULIN LEAKING NOTED AT THE SITE. AS TREATMENT, A NEW POD WAS PLACED. Manufacturer Narrative: THE RECEIVED DEVICE HAD THE CANNULA ASSEMBLY DEPLOYED. DURING INVESTIGATION, AN INTERNAL LEAK WAS OBSERVED IN THE FLUID PATH DUE TO A TEAR IN THE SOFT CANNULA. THIS LEAK RESULTED IN FLUID DIVERTING FROM THE INTENDED FLUID PATH. DUE TO THE DAMAGE ON THE INTERNAL PORTION OF THE SOFT CANNULA, THE EXPOSED PORTION OF THE SOFT CANNULA COULD NOT BE TESTED TO CONFIRM THE REPORTED EVENT. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2021/11/18 5:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 18.8 MMOL/L (338.4 MG/DL) WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. WHEN REMOVED FROM THE INFUSION SITE (HIP/BUTTOCKS), THE POD'S CANNULA WAS FOUND BENT. AS TREATMENT, A NEW POD WAS APPLIED AND A BOLUS WAS DELIVERED. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2021/11/21 5:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 15.8 MMOL/L (284.4 MG/DL) WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. WHEN REMOVED FROM THE INFUSION SITE (HIP/BUTTOCKS), THE POD'S CANNULA WAS FOUND BENT. AS TREATMENT, A NEW POD WAS APPLIED AND A BOLUS WAS DELIVERED. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2021/11/22 5:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 19.1 MMOL/L (343.8 MG/DL) WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. WHEN REMOVED FROM THE INFUSION SITE (HIP/BUTTOCKS), THE POD'S CANNULA WAS FOUND BENT. AS TREATMENT, A NEW POD WAS APPLIED AND A BOLUS WAS DELIVERED. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2021/11/30 5:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 15.1 MMOL/L (271.8 MG/DL) WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. WHEN REMOVED FROM THE INFUSION SITE (HIP/BUTTOCKS), THE POD'S CANNULA WAS FOUND BENT. AS TREATMENT, A NEW POD WAS APPLIED AND A BOLUS WAS DELIVERED. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/26 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMFailure to Fire No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THE PINK SLIDE DID NOT MOVE FORWARD AND THE CANNULA WAS NOT VISIBLE; INDICATING THE NEEDLE MECHANISM DID NOT DEPLOY. THE POD WAS NOT WORN AND NO ADVERSE PATIENT IMPACT WAS REPORTED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/28 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMFailure to Fire No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THE PINK SLIDE DID NOT MOVE FORWARD AND THE CANNULA WAS NOT VISIBLE; INDICATING THE NEEDLE MECHANISM DID NOT DEPLOY. THE POD WAS NOT WORN AND NO ADVERSE PATIENT IMPACT WAS REPORTED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/28 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMFailure to Fire No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THE PINK SLIDE DID NOT MOVE FORWARD AND THE CANNULA WAS NOT VISIBLE; INDICATING THE NEEDLE MECHANISM DID NOT DEPLOY. THE POD WAS NOT WORN AND NO ADVERSE PATIENT IMPACT WAS REPORTED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/28 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMPremature Activation No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THE NEEDLE MECHANISM FULLY DEPLOYED BEFORE THE POD WAS ABLE TO BE USED. THE POD WAS NOT WORN AND NO ADVERSE PATIENT IMPACT WAS REPORTED. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/25 4:00:00InjuryINSULET CORPORATIONOMNIPOD DASH, PODS 10-PACKInsufficient InformationHyperglycemia; Nausea; Pain; Vomiting; Diabetic KetoacidosisEvent Description: IT WAS REPORTED THAT THE PATIENT VISITED THE EMERGENCY ROOM (ER) DUE TO WHAT THEY THOUGHT TO BE DIABETIC KETOACIDOSIS (DKA). THE PATIENT'S BLOOD GLUCOSE (BG) READ "HIGH" (>27.8 MMOL/L) (>500MG/DL) WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS ON THE LEG. THE HEALTHCARE PROFESSIONAL DISCARDED THE POD. SYMPTOMS REPORTED INCLUDE HYPERGLYCEMIA, HIGH KETONES, VOMITING, NAUSEA AND STOMACH PAIN. THE PATIENT WAS TREATED WITH INTRAVENOUS FLUIDS, SALINE FLUIDS AND A NEW POD. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED HOSPITALIZATION AND HYPERGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/03/10 5:00:00InjuryINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMInsufficient InformationHyperglycemia; HypoglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT VISITED THE EMERGENCY ROOM (ER) DUE TO HYPERGLYCEMIA AND HYPOGLYCEMIA. THE PATIENT'S BLOOD GLUCOSE (BG) LEVELS REACHED A HIGH OF 435 MG/DL AND A LOW OF 53 MG/DL. THE POD WAS WORN LONGER THAN 48 HOURS ON THE ABDOMEN. THE PATIENT WAS TREATED WITH FLUIDS AND MANUAL INSULIN INJECTION. THE POD WAS DISCARDED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED HOSPITALIZATION AND HYPERGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/03/28 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMFailure to Fire No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THE NEEDLE MECHANISM DID NOT DEPLOY. THE POD WAS NOT WORN AND NO ADVERSE PATIENT IMPACT WAS REPORTED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/03/28 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 366 MG/DL WHILE WEARING THE POD BETWEEN 1 AND 4 HOURS. WHEN REMOVED FROM THE INFUSION SITE (BACK), THE POD'S CANNULA WAS FOUND BENT. AS TREATMENT, A NEW POD WAS APPLIED. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/01 5:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMFailure to Fire No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THE PINK SLIDE DID NOT MOVE FORWARD AND THE CANNULA WAS NOT VISIBLE; INDICATING THE NEEDLE MECHANISM DID NOT DEPLOY. THE POD WAS NOT WORN AND NO ADVERSE PATIENT IMPACT WAS REPORTED. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/01/17 5:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMInsufficient InformationHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVEL REACHED 300 MG/DL. THE POD WAS WORN ON THE ABDOMEN. HYPERGLYCEMIA TREATED WITH A NEW POD. Manufacturer Narrative: INSPECTION OF THE DEVICE FOUND A TEAR TO THE SOFT CANNULA. IT COULD NOT BE DETERMINED WHEN THIS DAMAGE OCCURRED, SO IT CANNOT BE DETERMINED IF THIS DAMAGE CAUSED THE FAILURE TO DELIVER INSULIN. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/23 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMUnintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 300 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. THE CANNULA DISLODGED FROM THE INFUSION SITE (HIP/BUTTOCKS). AS TREATMENT FOR HYPERGLYCEMIA, A MANUAL INJECTION OF INSULIN WAS DELIVERED AND A NEW POD WAS APPLIED. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/23 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 599 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. WHEN REMOVED FROM THE INFUSION SITE (ARM), THE POD'S CANNULA WAS FOUND BENT. AS TREATMENT FOR HYPERGLYCEMIA, A MANUAL INJECTION OF INSULIN WAS DELIVERED AND A NEW POD WAS APPLIED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/24 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMPremature Activation No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED BY THE PATIENT THAT THEY HAD A POD WHERE THE NEEDLE DEPLOYED EARLY BEFORE THE POD WAS APPLIED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/24 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMPremature Activation No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED BY THE PATIENT THAT THEY HAD A POD WHERE THE NEEDLE DEPLOYED EARLY BEFORE THE POD WAS APPLIED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/23 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 420 MG/DL WHILE WEARING THE POD BETWEEN 1 AND 4 HOURS. WHEN REMOVED FROM THE INFUSION SITE (ARM), THE POD'S CANNULA WAS FOUND BENT. AS TREATMENT, THE PATIENT ADMINISTERED A MANUAL INJECTION OF INSULIN AND APPLIED A NEW POD. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/23 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 420 MG/DL WHILE WEARING THE POD BETWEEN 1 AND 4 HOURS. WHEN REMOVED FROM THE INFUSION SITE (LEG), THE POD'S CANNULA WAS FOUND BENT. AS TREATMENT, THE PATIENT ADMINISTERED A MANUAL INJECTION OF INSULIN AND APPLIED A NEW POD. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/23 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO OVER 250 MG/DL WHILE WEARING THE POD BETWEEN 36 AND 48 HOURS. WHEN REMOVED FROM THE INFUSION SITE (BACK), THE POD'S CANNULA WAS FOUND BENT. AS TREATMENT, THE PATIENT EXERCISED, DRANK WATER AND APPLIED A NEW POD. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/23 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO OVER 360 MG/DL WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. WHEN REMOVED FROM THE INFUSION SITE (ARM), THE POD'S CANNULA WAS FOUND BENT. AS TREATMENT, THE PATIENT EXERCISED, DRANK WATER AND APPLIED A NEW POD. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/24 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMPremature Activation No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED BY THE PATIENT THAT THEY HAD A POD WHERE THE NEEDLE DEPLOYED EARLY BEFORE THE POD WAS APPLIED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/23 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Material Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 272 MG/DL WHILE WEARING THE POD BETWEEN 1 AND 4 HOURS. WHEN REMOVED FROM THE INFUSION SITE (ARM), THE POD'S CANNULA WAS FOUND BENT. AS TREATMENT, A NEW POD WAS APPLIED. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/28 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 400 MG/DL WHILE WEARING THE POD BETWEEN 36 AND 48 HOURS. WHEN REMOVED FROM THE INFUSION SITE (LEG), THE POD'S CANNULA WAS FOUND BENT. AS TREATMENT, A MANUAL INJECTION OF INSULIN WAS DELIVERED AND A NEW POD WAS APPLIED. THIS POD WAS DISCARDED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/03/27 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMFluid Leak; Difficult to Insert; Material Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE (BG) LEVELS REACHED 400 MG/DL WHILE WEARING THE POD BETWEEN 36 AND 48 HOURS. DUE TO ELEVATED BG LEVELS AND THE FACT THAT THE POD WAS LEAKING, PATIENT WAS UNSURE IF CANNULA HAD PROPERLY INSERTED IN THE INFUSION SITE (LEG). AS TREATMENT, A NEW POD WAS APPLIED. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. IT WAS REPORTED THE CANNULA WAS POSSIBLY NOT INSERTED CORRECTLY INTO THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. WE ARE ALSO UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS. ADDITIONALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/26 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 270 MG/DL WHILE WEARING THE POD LONGER THAN 48 HOURS. WHEN REMOVED FROM THE INFUSION SITE (LEG), THE POD'S CANNULA WAS FOUND BENT. AS TREATMENT, A MANUAL INJECTION OF INSULIN WAS DELIVERED AND A NEW POD WAS APPLIED. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/27 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 305 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. WHEN REMOVED FROM THE INFUSION SITE (BACK), THE POD'S CANNULA WAS FOUND BENT. AS TREATMENT, MANUAL INJECTIONS OF INSULIN WERE DELIVERED. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/25 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMFluid Leak; Material Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT DESPITE DELIVERING CORRECTIONS, THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 363 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. PATIENT REPORTED THE POD WAS LEAKING DURING WEAR. WHEN REMOVED FROM THE INFUSION SITE (ARM), THE POD'S CANNULA WAS FOUND BENT. AS TREATMENT, A MANUAL INJECTION OF INSULIN WAS DELIVERED AND PATIENT DRANK FLUIDS. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/28 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMDifficult to InsertHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE (BG) LEVELS REACHED OVER 300 MG/DL WHILE WEARING THE POD. DUE TO ELEVATED BG LEVELS, PATIENT WAS UNSURE IF CANNULA HAD PROPERLY INSERTED IN THE INFUSION SITE (ARM). AS TREATMENT, A BOLUS WAS DELIVERED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THE CANNULA WAS POSSIBLY NOT INSERTED CORRECTLY INTO THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/01/17 5:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMInsufficient InformationHyperglycemiaEvent Description: IT WAS REPORTED WHILE A PATIENT HAD BEEN WEARING A POD BETWEEN 36 AND 48 HOURS THEIR BLOOD GLUCOSE LEVEL HAD ROSE TO 275 MG/DL. AS TREATMENT, THE PATIENT ADMINISTERED A MANUAL INJECTION OF INSULIN. Manufacturer Narrative: THE RETURNED DEVICE WAS EVALUATED AND THE INSPECTION OF THE CANNULA ASSEMBLY FOUND NO PROBLEMS WITH FLUID PASSING FREELY THROUGH THE COMPLETE FLUID PATH, THOUGH THE EXPOSED PORTION OF THE SOFT CANNULA WAS FLATTENED. IT COULD NOT BE DETERMINED WHEN THIS DAMAGE OCCURRED. THE DOWNLOAD DATA DOES NOT CONTAIN ANY TIMEOUTS OR PULSE WIDTH INCREASES THAT WOULD INDICATE A FAILURE TO DELIVER INSULIN. NO OTHER DAMAGES OR MANUFACTURING DEFICIENCIES WERE FOUND THAT WOULD RESULT IN THE DEVICE FAILING TO DELIVER INSULIN. CRACKS WERE OBSERVED IN THE BOTTOM HOUSING OF THE POD. IT COULD NOT BE DETERMINED WHEN THESE CRACKS OCCURRED. INVESTIGATION OF THE POD AND THE DOWNLOAD DATA FROM THE POD INDICATE THAT THE CRACKS DID NOT AFFECT THE FUNCTIONALITY OF THE POD. CORROSION WAS OBSERVED ON THE PCB BOARD OF THE DEVICE. IT COULD NOT BE CONCLUSIVELY DETERMINED IF THE CRACKS IN THE BOTTOM HOUSING WERE THE CAUSE OF THIS CORROSION. WHEN THIS CORROSION OCCURRED COULD NOT BE DETERMINED. THE EXACT CAUSE OF THE CORROSION COULD NOT BE DETERMINED. THE CORROSION DID NOT AFFECT THE PODS ABILITY TO OBTAIN THE DOWNLOAD DATA. THE DOWNLOAD DATA SHOWS THE GENERATION OF AN 0X1C ALARM DURING OPERATION, INDICATING THE PUMP HAD REACHED THE PUMP EXPIRATION TIME. THE DOWNLOAD DATA SHOWS THE ALARM TIME WAS 80 HOURS, INDICATING THE DEVICE HAD REACHED IT'S EXPIRATION TIME. THE POD HAD FUNCTIONED AS INTENDED. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/02/25 5:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 400 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. WHEN REMOVED FROM THE INFUSION SITE (ARM), THE POD'S CANNULA WAS FOUND BENT. AS TREATMENT FOR HYPERGLYCEMIA, 2 CORRECTIONS WERE DELIVERED AND A NEW POD WAS APPLIED. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/24 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 300 MG/DL WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. WHEN REMOVED FROM THE INFUSION SITE (ARM), THE POD'S CANNULA LOOKED BENT. AS TREATMENT FOR HYPERGLYCEMIA, A NEW POD WAS APPLIED. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/21 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMFluid Leak; Failure to Fire No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED BY THE PATIENT THAT THE CANNULA DID NOT COME OUT WHEN ACTIVATING A NEW POD. THE PATIENT ALSO NOTICED INSULIN WAS LEAKING. THE POD WAS WORN LESS THAN AN HOUR ON THE INFUSION SITE (ABDOMEN). AS TREATMENT, THE PATIENT WAS ABLE TO REMOVE THE POD AND ACTIVATE A NEW POD. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/24 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemia; Swelling/ EdemaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 347 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. WHEN REMOVED FROM THE INFUSION SITE (UNKNOWN), THE POD'S CANNULA WAS FOUND BENT. IT WAS ALSO NOTICED THAT THERE WAS A LITTLE BUMP AND DRIED BLOOD ON THE SITE. AS TREATMENT, THE PATIENT SUCCESSFULLY WAS ABLE TO ACTIVATED A NEW POD. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/24 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) ROSE TO 475 MG/DL WHILE WEARING THE POD LONGER THAN 48 HOURS. THE POD REPORTEDLY WAS COMING LOOSE FROM THE INFUSION SITE (LEG), CAUSING THE CANNULA TO DISLODGE. AS TREATMENT, A NEW POD WAS APPLIED. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/24 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) ROSE IN THE 400S MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. THE POD REPORTEDLY FELL OFF THE INFUSION SITE (LEG), CAUSING THE CANNULA TO DISLODGE. AS TREATMENT, THE PATIENT SUCCESSFULLY ACTIVATED A NEW POD. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/25 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) ROSE TO 400 MG/DL WHILE WEARING THE POD FOR AN UNKNOWN AMOUNT OF TIME. THE POD REPORTEDLY GOT RIPPED OFF THE INFUSION SITE (ARM) BY HITTING THE DOOR, CAUSING THE CANNULA TO DISLODGE. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/03/25 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) ROSE TO THE 300S MG/DL WHILE WEARING THE POD BETWEEN 1 AND 4 HOURS. THE POD REPORTEDLY FELL OFF THE INFUSION SITE (HIP/BUTTOCKS), CAUSING THE CANNULA TO DISLODGE. AS TREATMENT, THE PATIENT WAS ABLE TO ACTIVATED ANOTHER POD. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/25 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) ROSE TO 400 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. THE POD REPORTEDLY FELL OFF THE INFUSION SITE (LEG), CAUSING THE CANNULA TO DISLODGE. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/25 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM Activation, Positioning or SeparationProblemHyperglycemiaEvent Description: IT WAS REPORTED THAT DESPITE DELIVERING A BOLUS, THE PATIENT¿S BLOOD GLUCOSE (BG) LEVEL REACHED 354 MG/DL WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS ON THE BACK. AFTER REALIZING ELEVATED BG LEVELS, PATIENT FOUND THE PINK SLIDE DID NOT MOVE FORWARD AS INTENDED; THIS INDICATES THAT A NEEDLE MECHANISM FAILURE OCCURRED. AS TREATMENT, A MANUAL INJECTION WAS DELIVERED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/26 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMFailure to Fire No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT THE CANNULA DID NOT DEPLOY WHEN THE POD WAS ACTIVATED; THIS INDICATES A NEEDLE MECHANISM FAILURE OCCURRED. THE POD WAS WORN FOR LESS THAN ONE HOUR AND WAS DISCARDED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/17 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMFailure to Fire No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT THE CANNULA DID NOT DEPLOY WHEN THE POD WAS ACTIVATED; THIS INDICATES A NEEDLE MECHANISM FAILURE OCCURRED. THE POD WAS NOT WORN. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/28 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMFailure to Fire No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT THE CANNULA DID NOT DEPLOY WHEN THE POD WAS ACTIVATED; THIS INDICATES A NEEDLE MECHANISM FAILURE OCCURRED. THE POD WAS WORN BETWEEN 24 AND 36 HOURS. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/23 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMPremature Activation No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT THE NEEDLE WAS DEPLOYED EARLY, BEFORE THE ACTIVATION PROCESS WAS COMPLETE. THIS INDICATED A NEEDLE MECHANISM FAILURE. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/26 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMFluid Leak; Material Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO ALMOST 400 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. WHEN REMOVED FROM THE INFUSION SITE (ARM), THE POD'S CANNULA WAS FOUND BENT. IT WAS ALSO STATED THAT THE PATIENT COULD SMELL AND FEEL INSULIN ON THERE SKIN. AS TREATMENT, THE PATIENT RESUMED TREATMENT ON A NEW POD. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/26 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) ROSE TO 264 MG/DL WHILE WEARING THE POD BETWEEN 36 AND 48 HOURS. THE POD REPORTEDLY FELL OFF THE INFUSION SITE (ARM), CAUSING THE CANNULA TO DISLODGE. AS TREATMENT, THE PATIENT WILL PUT A NEW POD ON AFTER THE PHONE CALL IS DONE. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/23 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Unintended MovementHyperglycemia; PainEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) ROSE TO 400'S MG/DL WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. THE POD REPORTEDLY FELL OFF THE INFUSION SITE (LEG), CAUSING THE CANNULA TO DISLODGE. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED PAIN. AS TREATMENT, A NEW POD WAS SUCCESSFULLY ACTIVATED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/26 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) ROSE TO 400 MG/DL WHILE WEARING THE POD BETWEEN 1 AND 4 HOURS. THE POD REPORTEDLY FELL OFF THE INFUSION SITE (ABDOMEN), CAUSING THE CANNULA TO DISLODGE. AS TREATMENT, A NEW POD WAS APPLIED. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/26 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) ROSE TO 400 MG/DL WHILE WEARING THE POD BETWEEN 1 AND 4 HOURS. THE POD REPORTEDLY FELL OFF THE INFUSION SITE (ABDOMEN), CAUSING THE CANNULA TO DISLODGE. AS TREATMENT, A NEW POD WAS APPLIED. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/27 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) ROSE TO 498 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. THE POD REPORTEDLY FELL OFF THE INFUSION SITE (ABDOMEN), CAUSING THE CANNULA TO DISLODGE. AS TREATMENT, A NEW POD WAS APPLIED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/27 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Material Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 260 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. THE POD WAS REPORTEDLY NOT STICKING WILL FROM THE INFUSION SITE (ABDOMEN), WHEN REMOVED THE POD'S CANNULA WAS FOUND BENT. AS TREATMENT, A NEW POD WAS APPLIED. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/27 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMFluid Leak; Material Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 286 MG/DL WHILE WEARING THE POD LONGER THAN 48 HOURS. THE POD WAS LEAKING INSULIN FROM THE INFUSION SITE (BACK), WHEN REMOVED THE POD'S CANNULA WAS FOUND BENT. AS TREATMENT, A NEW POD WAS APPLIED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/29 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Fluid Leak; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) ROSE TO 468 MG/DL WHILE WEARING THE POD BETWEEN 1 AND 4 HOURS. THE POD REPORTEDLY WAS LEAKING AND THE ADHESIVE WAS COMING LOOSE FROM THE INFUSION SITE (LEG), CAUSING THE CANNULA TO DISLODGE. NO TREATMENT WAS PROVIDED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/15 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) ROSE TO 400 MG/DL WHILE WEARING THE POD BETWEEN 1 AND 4 HOURS. THE POD REPORTEDLY FELL OFF THE INFUSION SITE (ABDOMEN), CAUSING THE CANNULA TO DISLODGE. AS TREATMENT THE PATIENT REPLACED THE POD. THE PATIENT HAS DISCARDED THE POD. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/21 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMUnintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 400 MG/DL WHILE WEARING THE POD BETWEEN 36 AND 48 HOURS. WHEN REMOVED FROM THE INFUSION SITE (ARM), THE POD'S CANNULA WAS FOUND TO BE DISLODGED. AS TREATMENT THE PATIENT REPLACED THE POD. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/20 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) ROSE TO 300 MG/DL WHILE WEARING THE POD BETWEEN 36 AND 48 HOURS. THE POD REPORTEDLY FELL OFF THE INFUSION SITE (ABDOMEN), CAUSING THE CANNULA TO DISLODGE. AS TREATMENT THE PATIENT REPLACED THE POD. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/19 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) ROSE TO AROUND 300 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. THE POD REPORTEDLY WAS NO LONGER INSERTED AT THE INFUSION SITE (ABDOMEN), CAUSING THE CANNULA TO DISLODGE. AS TREATMENT, A NEW POD WAS APPLIED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/15 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) ROSE UP TO 24.5 MMOL/L (441 MG/DL) WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. THE DETAILED BG LEVELS ARE AS FOLLOWS: (B)(6). THE POD REPORTEDLY WAS COMING LOOSE FROM THE INFUSION SITE (ABDOMEN), CAUSING THE CANNULA TO DISLODGE. AS TREATMENT, A NEW POD WAS APPLIED AND A CORRECTION BOLUS OF 8 UNITS WAS ADMINISTERED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/28 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT A PATIENT'S BLOOD GLUCOSE LEVELS (BG) REACHED 400 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. THE PATIENT REPORTED CANNULA BEING BENT WHILE WEARING IT ON THE ABDOMEN. FOR TREATMENT, THE PATIENT CHANGED OUT THE POD FOR A NEW POD. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/24 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT A PATIENT'S BLOOD GLUCOSE LEVELS (BG) REACHED 452 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. THE PATIENT REPORTED CANNULA BEING BENT WHILE WEARING IT ON THE ABDOMEN. FOR TREATMENT, THE PATIENT CHANGED OUT THE POD FOR A NEW POD AND GAVE FLUIDS. THE POD WAS DISCARDED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/28 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMFluid Leak; Material Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT A PATIENT'S BLOOD GLUCOSE LEVELS (BG) REACHED 390 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. THE PATIENT REPORTED CANNULA BEING BENT WHILE WEARING IT ON THE ARM. FOR TREATMENT, THE PARENT CHANGED OUT THE POD. THE POD WAS LEAKING AND WAS DISCARDED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2021/12/26 5:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT A PATIENT'S BLOOD GLUCOSE LEVELS (BG) REACHED OVER 250 MG/DL WHILE WEARING THE POD LONGER THAN 48 HOURS. THE PATIENT REPORTED CANNULA BEING BENT WHILE WEARING IT ON THE LEG. FOR TREATMENT, THE PATIENT CHANGED OUT THE POD FOR A NEW POD. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/28 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT A PATIENT'S BLOOD GLUCOSE LEVELS (BG) REACHED 300 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. THE PATIENT REPORTED CANNULA BEING BENT WHILE WEARING IT ON THE ABDOMEN. FOR TREATMENT, THE PATIENT CHANGED OUT THE POD FOR A NEW POD. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/28 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT A PATIENT'S BLOOD GLUCOSE LEVELS (BG) REACHED 315 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. THE PATIENT REPORTED CANNULA BEING BENT WHILE WEARING IT ON THE HIPS/BUTTOCKS. FOR TREATMENT, THE PATIENT GAVE CORRECTION BOLUSES. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/28 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMFluid Leak; Material Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT A PATIENT'S BLOOD GLUCOSE LEVELS (BG) REACHED OVER 250 MG/DL WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. THE PATIENT REPORTED CANNULA BEING BENT WHILE WEARING IT ON THE ABDOMEN. FOR TREATMENT, THE PATIENT CHANGED OUT THE POD FOR A NEW POD. THE POD WAS LEAKING. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/26 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Material Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT A PATIENT'S BLOOD GLUCOSE LEVELS (BG) REACHED 300 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. THE PATIENT REPORTED CANNULA BEING BENT WHILE WEARING IT ON THE ARM. FOR TREATMENT, MANUAL INJECTION WAS ADMINISTERED. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/27 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 270 MG/DL WHILE WEARING THE POD LONGER THAN 48 HOURS. PATIENT STATED THE POD WAS FALLING OFF AND THE CANNULA DISLODGED FROM THE INFUSION SITE (ARM). BLEEDING AT THE SITE WAS ALSO REPORTED. AS TREATMENT, A NEW POD WAS APPLIED. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/28 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN PUMPUnintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED OVER 600 MG/DL WHILE WEARING THE POD. PATIENT STATED THE CANNULA DISLODGED FROM THE INFUSION SITE. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/03/23 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMUnintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 300 MG/DL WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. PATIENT STATED THE CANNULA DISLODGED FROM THE INFUSION SITE (LEG). AS TREATMENT, INSULIN WAS DELIVERED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/28 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN PUMPUnintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED OVER 600 MG/DL WHILE WEARING THE POD. PATIENT STATED THE CANNULA DISLODGED FROM THE INFUSION SITE. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/03/28 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED ALMOST 400 MG/DL WHILE WEARING THE POD. PATIENT STATED THE ADHESIVE WAS NOT SECURE AND THE CANNULA DISLODGED FROM THE INFUSION SITE (ABDOMEN). Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/28 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED OVER 600 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. PATIENT STATED THE POD FELL OFF AND THE CANNULA DISLODGED FROM THE INFUSION SITE (ABDOMEN). MODERATE TO HIGH KETONES WERE ALSO PRESENT. AS TREATMENT, A MANUAL INJECTION WAS DELIVERED AND PATIENT DRANK WATER. PATIENT WAS TAKEN TO DOCTOR, BUT NO TREATMENT WAS GIVEN AND IT WAS ONLY ADVISED THAT THEY CONTINUE WITH INJECTIONS. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/18 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN PUMPFluid Leak; Material Twisted/BentHyperglycemia; Skin Inflammation/ IrritationEvent Description: IT WAS REPORTED THAT A PATIENT'S BLOOD GLUCOSE LEVELS (BG) REACHED 324 MG/DL WHILE WEARING THE POD BETWEEN 36 AND 48 HOURS. THE PATIENT REPORTED CANNULA BEING BENT WHILE WEARING IT ON THE ABDOMEN. FOR TREATMENT, MANUAL INJECTION WAS ADMINISTERED. THE POD WAS LEAKING. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/27 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN PUMPFluid Leak; Material Twisted/BentHyperglycemia; Skin Inflammation/ IrritationEvent Description: IT WAS REPORTED THAT A PATIENT'S BLOOD GLUCOSE LEVELS (BG) REACHED 392 MG/DL WHILE WEARING THE POD BETWEEN 36 AND 48 HOURS. THE PATIENT REPORTED CANNULA BEING BENT WHILE WEARING IT ON THE ABDOMEN. FOR TREATMENT, MANUAL INJECTION WAS ADMINISTERED. THE POD WAS LEAKING. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/28 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMDifficult to Insert; Material Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 300 MG/DL WHILE WEARING THE POD BETWEEN 36 AND 48 HOURS. THEY SAW THAT THE CANNULA DID NOT GO IN FULLY. WHEN REMOVED FROM THE INFUSION SITE (ARM), THE POD'S CANNULA WAS FOUND BENT. AS TREATMENT FOR HYPERGLYCEMIA, A NEW POD WAS APPLIED. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA NOT INSERTING PROPERLY OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/25 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMPremature Activation No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED BY THE PATIENT THAT THEY HAD A POD WHERE THE NEEDLE DEPLOYED EARLY BEFORE THE POD WAS APPLIED. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2021/12/07 5:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMInsufficient InformationHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 500 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS ON THE ABDOMEN. Manufacturer Narrative: THE DEVICE WAS RECEIVED FULLY DEPLOYED. DURING INVESTIGATION, NO BLOCKAGES WERE FOUND IN THE FLUID PATH AND FLUID WAS OBSERVED FLOWING FREELY THOUGH THE SOFT CANNULA. NO DAMAGES OR DEFECTS WERE OBSERVED ON THE DRIVE MECHANISM THAT WOULD CONTRIBUTE TO THE 0X67 ALARM. THE ROOT CAUSE OF THE OCCLUSION ALARM COULD NOT BE DETERMINED. INSPECTION OF THE CANNULA ASSEMBLY FOUND THE EXPOSED PORTION OF THE SOFT CANNULA TO BE TORN AND SHORTENED. IT COULD NOT BE CONCLUSIVELY DETERMINED WHEN OR HOW THIS DAMAGE OCCURRED. DUE TO THE DAMAGE TO THE SOFT CANNULA, FLUID WAS UNABLE TO FLOW THROUGH THE ENTIRE FLUID PATH. NO OTHER DAMAGES OR MANUFACTURING DEFICIENCIES WERE FOUND THAT WOULD RESULT IN THE DEVICE FAILING TO DELIVER INSULIN. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/11 5:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN PUMP Fluid Leak; Activation, Positioning or SeparationProblem; Material Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT¿S BLOOD GLUCOSE (BG) REACHED 278 MG/DL WHILE WEARING THE POD LONGER THAN 48 HOURS ON THE BACK. IT WAS DISCOVERED THAT THE PINK SLIDE INSERT DID NOT MOVE INTO THE VIEWING WINDOW, WHICH INDICATES A FAILURE OF THE NEEDLE MECHANISM TO DEPLOY AS INTENDED DURING ACTIVATION. THE PATIENT REPORTED CANNULA BEING BENT. AS TREATMENT, MANUAL INJECTION WAS ADMINISTERED OF 2 UNITS OF INSULIN. THE POD WAS LEAKING. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/28 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMFailure to Fire Hyperglycemia; No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT THE PATIENT FOUND CANNULA HAD NOT DEPLOYED AS INTENDED. THE CANNULA WAS NOT VISIBLE AND THE PINK SLIDE DID NOT MOVE FORWARD, INDICATING A NEEDLE MECHANISM FAILURE. THE POD WAS DISCARDED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/03/28 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMFailure to Fire No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT THE PATIENT FOUND CANNULA HAD NOT DEPLOYED AS INTENDED. THE CANNULA WAS NOT VISIBLE, INDICATING A NEEDLE MECHANISM FAILURE. THE PATIENT'S BLOOD GLUCOSE (BG) VALUES REACHED 167 MG/DL. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/25 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THAT A PATIENT'S BLOOD GLUCOSE LEVELS (BG) REACHED 320 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. THE PATIENT REPORTED CANNULA BEING DISLODGED, WHILE WEARING IT ON THE HIPS/BUTTOCKS. FOR TREATMENT, THE PATIENT GAVE CORRECTION BOLUSES. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/28 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMPremature ActivationHyperglycemiaEvent Description: IT WAS REPORTED THAT THE NEEDLE MECHANISM HAD FULLY DEPLOYED BEFORE THE POD WAS ABLE TO BE USED. THE PATIENT'S BLOOD GLUCOSE (BG) VALUES REACHED 300 MG/DL. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/28 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT A PATIENT'S BLOOD GLUCOSE LEVELS (BG) REACHED 380 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. THE PATIENT REPORTED CANNULA BEING BENT WHILE WEARING IT ON UNKNOWN LOCATION. FOR TREATMENT, THE PATIENT CHANGED OUT THE POD FOR A NEW POD. THE POD WAS DISCARDED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/28 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMUnintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THAT A PATIENT'S BLOOD GLUCOSE LEVELS (BG) REACHED 464 MG/DL WHILE WEARING THE POD BETWEEN 1 AND 4 HOURS. THE PATIENT REPORTED CANNULA BEING DISLODGED, WHILE WEARING IT ON THE ABDOMEN. FOR TREATMENT, THE PATIENT CHANGED OUT THE POD AND GAVE CORRECTION BOLUS. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/15 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Material Twisted/Bent; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THAT A PATIENT'S BLOOD GLUCOSE LEVELS (BG) REACHED 261 MG/DL WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. THE PATIENT REPORTED CANNULA BEING DISLODGED AND BENT, WHILE WEARING IT ON UNKNOWN LOCATION. FOR TREATMENT, THE PATIENT CHANGED OUT THE POD FOR A NEW POD. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED AND BENT FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/01/21 5:00:00InjuryINSULET CORPORATIONOMNIPOD INSULIN PUMPAdverse Event Without Identified Device or Use ProblemHypoglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT WAS TAKE TO THE EMERGENCY ROOM (ER) BY AMBULANCE AND WAS DIAGNOSED WITH BLOOD GLUCOSE (BG) VALUES DROPPED TO 33 MG/DL. FOR TREATMENT, THE PATIENT WAS GIVEN INTRAVENOUS (IV) DEXTROSE. THE POD WAS WORN BETWEEN 4 AND 24 HOURS ON THE ABDOMEN. THE PATIENT WAS DISCHARGED AFTER 2.5 HOURS. THE POD WAS DISCARDED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED HOSPITALIZATION AND HYPOGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/03/26 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT A PATIENT'S BLOOD GLUCOSE LEVELS (BG) REACHED 380 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. THE PATIENT REPORTED CANNULA BEING BENT WHILE WEARING IT ON UNKNOWN LOCATION. FOR TREATMENT, THE PATIENT CHANGED OUT THE POD FOR A NEW POD. THE POD WAS DISCARDED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/21 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMMaterial Twisted/Bent; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THAT A PATIENT'S BLOOD GLUCOSE LEVELS (BG) REACHED 293 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. THE PATIENT REPORTED CANNULA BEING DISLODGED AND BENT, WHILE WEARING IT ON UNKNOWN LOCATION. FOR TREATMENT, THE PATIENT CHANGED OUT THE POD FOR A NEW POD. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED AND BENT FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/17 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT A PATIENT'S BLOOD GLUCOSE LEVELS (BG) REACHED 280 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. THE PATIENT REPORTED CANNULA BEING BENT WHILE WEARING IT ON THE ARM. FOR TREATMENT, THE PATIENT CHANGED OUT THE POD FOR A NEW POD. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/27 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMFluid Leak; Material Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT A PATIENT'S BLOOD GLUCOSE LEVELS (BG) REACHED 354 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. THE PATIENT REPORTED CANNULA BEING BENT WHILE WEARING IT ON THE ARM. FOR TREATMENT, THE PATIENT CHANGED OUT THE POD AND GAVE A MANUAL INJECTION. THE POD WAS LEAKING. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/03/07 5:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMPremature Activation No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT THE NEEDLE MECHANISM HAD FULLY DEPLOYED BEFORE THE POD WAS ABLE TO BE USED. THE POD WAS DISCARDED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/24 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Material Twisted/Bent; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THAT A PATIENT'S BLOOD GLUCOSE LEVELS (BG) REACHED OVER 400 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. THE PATIENT REPORTED CANNULA BEING DISLODGED, WHILE WEARING IT ON THE ARM. FOR TREATMENT, THE PARENT CHANGED OUT THE POD AND GAVE A MANUAL INJECTION. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED AND BENT FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/25 4:00:00InjuryINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMInsufficient InformationInsufficient InformationEvent Description: IT WAS REPORTED THAT THE PATIENT WENT TO THE HOSPITAL FOR HIGH BLOOD GLUCOSE (BG) VALUES. NO FURTHER DETAILS AVAILABLE. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED HOSPITALIZATION. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/03/29 4:00:00InjuryINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMInsufficient InformationHeadache; Hypoglycemia; Vomiting; Abdominal CrampsEvent Description: IT WAS REPORTED THAT THE PATIENT WENT TO THE EMERGENCY ROOM (ER) AND WAS DIAGNOSED WITH BLOOD GLUCOSE (BG) VALUES DROPPED TO 55 MG/DL. THE PATIENT HAD A MIGRAINE HEADACHE, WAS VOMITING AND HAD STOMACH PAIN. FOR TREATMENT, THE PATIENT WAS GIVEN INTRAVENOUS (IV) TORADOL AT 30 ML AND MORPHINE AT 4 ML. THE PATIENT WAS ALSO GIVEN ZOFRAN AT 4 ML AND PRESCRIBED ZOFRAN AT 4 MG TO TAKE EVERY 8 HOURS FOR 20 HOURS. THE POD WAS WORN BETWEEN 4 AND 24 HOURS ON THE ABDOMEN. THE PATIENT WAS DISCHARGED AFTER 7.5 HOURS. THE POD WAS DISCARDED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED HOSPITALIZATION AND HYPOGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/01 5:00:00InjuryINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMInsufficient InformationSkin InfectionEvent Description: IT WAS REPORTED THAT AFTER WEARING THE POD ON THE LEG LONGER THAN 48 HOURS, THE SITE WAS INFECTED. THE PATIENT CONSULTED THE GENERAL PRACTITIONER (GP) WHO PRESCRIBED ANTIBIOTICS ON TABLET CREAM FORM (NAMES UNSPECIFIED) TO BE TAKEN 3 TIMES A DAY. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO CUSTOMER'S INFUSION SITE INFECTION. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/02/25 5:00:00InjuryINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT VISITED THE EMERGENCY ROOM (ER) DUE TO HIGH BLOOD GLUCOSE (BG) LEVELS OF 16 MMOL/L (288 MG/DL) AND A LUMP AT THE SITE (ARM) AFTER WEARING THE POD BETWEEN 4 AND 24 HOURS. THE CANNULA WAS NOTED TO BE BENT AFTER REMOVAL. HYPERGLYCEMIA WAS TREATED WITH A MANUAL INSULIN INJECTION. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED ER VISIT AND HYPERGLYCEMIA. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, FREEDOM FROM HAZARD ALARMS AND CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/02/23 5:00:00InjuryINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMInsufficient InformationSkin Inflammation/ IrritationEvent Description: IT WAS REPORTED THAT AFTER WEARING THE POD ON THE HIP/BUTTOCKS AREA BETWEEN 4 AND 24 HOURS, THE SITE WAS INFLAMED WITH BLUEISH COLOR. THE PATIENT CONTACTED THE DOCTOR, WHO PRESCRIBED ANTIBIOTICS (NAME UNSPECIFIED) TO BE TAKEN FOR 5 DAYS. THE POD HAS BEEN DISCARDED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE AVAILABLE FOR INVESTIGATION BECAUSE IT WAS DISCARDED BY THE PATIENT. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE SKIN IRRITATION. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/03/17 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN PUMPDifficult to Insert; Material Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S GLUCOSE REACHED 22 MMOL/L (396 MG/DL) WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS ON THE LEG. UPON REMOVAL, IT WAS NOTICED THAT THE CANNULA WAS NOT PROPERLY INSERTED INTO THE SKIN AND WAS BENT. A NEW POD WAS APPLIED TO TREAT THE HYPERGLYCEMIA. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. IT WAS REPORTED THE CANNULA WAS POSSIBLY NOT INSERTED CORRECTLY INTO THE INFUSION SITE AND WAS BENT. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, FREEDOM FROM HAZARD ALARMS AND CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/19 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 500 MG/DL WHILE WEARING THE POD BETWEEN 36 AND 48 HOURS. WHEN REMOVED FROM THE INFUSION SITE (ARM), THE POD'S CANNULA WAS FOUND BENT. AS TREATMENT FOR HYPERGLYCEMIA, INJECTIONS OF INSULIN WERE DELIVERED AND A NEW POD WAS APPLIED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/21 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN PUMPFailure to Fire No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED BY THE PATIENT THAT THE CANNULA DID NOT DEPLOY OR INSERT AS INTENDED DURING ACTIVATION. THE PINK SLIDE WAS NOT FORWARD, INDICATING A NEEDLE MECHANISM FAILURE. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/14 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 454 MG/DL WHILE WEARING THE POD BETWEEN 1 AND 4 HOURS. WHEN REMOVED FROM THE INFUSION SITE (ABDOMEN), THE POD'S CANNULA WAS FOUND BENT. AS TREATMENT FOR HYPERGLYCEMIA, A MANUAL INJECTION OF INSULIN WAS DELIVERED AND A NEW POD WAS APPLIED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/03/21 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 350 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. WHEN REMOVED FROM THE INFUSION SITE, THE POD'S CANNULA WAS FOUND BENT. AS TREATMENT FOR HYPERGLYCEMIA, A MANUAL INJECTION OF INSULIN WAS DELIVERED AND A NEW POD WAS APPLIED., Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/19 4:00:00InjuryINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMInsufficient InformationHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT HAD BEEN HOSPITALIZED WITH HYPERGLYCEMIA. THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 439 MG/DL WHILE WEARING THE POD ON THE ARM FOR BETWEEN 4 AND 24 HOURS. DURING A ROUTINE DOCTOR CHECKUP, AN A1C BLOOD TEST WAS PERFORMED AND THE PATIENT WAS REFERRED TO THE EMERGENCY ROOM. THE PATIENT WAS TREATED WITH INSULIN VIA INTRAVENOUS THERAPY. THE POD WAS DISCARDED. Manufacturer Narrative: WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED HOSPITALIZATION AND HYPERGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED. HIGH BLOOD GLUCOSE IS A COMMON SYMPTOM FOR PEOPLE WITH DIABETES (GLUCOSE MONITORING DATA FROM PEOPLE WITH DIABETES INDICATE THAT ON AVERAGE, THEY CAN EXPERIENCE BLOOD GLUCOSE LEVELS ABOVE 250 MG/DL FOR 14-25% OF THE TIME, AND IT WOULD BE CHALLENGING TO SPECULATE ON A CAUSE FOR THE COMPLAINTS WITHOUT RECEIVING THE DEVICES BACK FOR AN ENGINEERING INVESTIGATION. BECK RW, BERGENSTAL RM, CHENG P, KOLLMAN C, CARLSON AL, JOHNSON ML, RODBARD D. THE RELATIONSHIPS BETWEEN TIME IN RANGE, HYPERGLYCEMIA METRICS, AND HBA1C. J DIABETES SCI TECHNOL 2019;13:614-626. WELSH JB, DERDZINSKI M, PARKER AS, PUHR S, JIMENEZ A, WALKER T. REAL-TIME SHARING AND FOLLOWING OF CONTINUOUS GLUCOSE MONITORING DATA IN YOUTH. DIABETES THER 2019;10:751-755. PUHR S, DERDZINSKI M, WELSH JB, PARKER AS, WALKER T, PRICE DA. REAL-WORLD HYPOGLYCEMIA AVOIDANCE WITH A CONTINUOUS GLUCOSE MONITORING SYSTEM'S PREDICTIVE LOW GLUCOSE ALERT. DIABETES TECHNOL THER 2019;21:155-158.
2022/03/19 4:00:00InjuryINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMInsufficient InformationSkin Inflammation/ IrritationEvent Description: IT WAS REPORTED THAT THE PATIENT DEVELOPED IRRITATIONS AT THE INFUSION SITE WHILE WEARING THE POD FOR LONGER THAN 48 HOURS ON THE LEG. THE PATIENT PHONED A PHYSICIAN AND SENT PHOTOS VIA ZOOM AND WAS PRESCRIBED FLUCLOXACILLIN (500MG) FOR 4 TIMES A DAY FOR 2 WEEKS. THE POD WAS DISCARDED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE SKIN IRRITATION. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/03/21 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMPremature Activation No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED BY THE PATIENT THAT THEY HAD A POD WHERE THE NEEDLE DEPLOYED EARLY BEFORE THE POD WAS APPLIED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/03/14 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 543 MG/DL WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. WHEN REMOVED FROM THE INFUSION SITE (ABDOMEN), THE POD'S CANNULA WAS FOUND BENT. AS TREATMENT FOR HYPERGLYCEMIA, A CORRECTION INJECTION OF INSULIN WAS DELIVERED, (B)(6) WAS CONSUMED AND A NEW POD WAS APPLIED. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/22 4:00:00InjuryINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMInsufficient InformationHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT HAD BEEN HOSPITALIZED WITH HYPERGLYCEMIA AND HIGH KETONE LEVELS. THE PATIENT'S BLOOD GLUCOSE (BG) READ "HIGH" (>27.8 MMOL/L) (>500MG/DL) WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. THE PATIENT WAS PLACED UNDER OBSERVATION AND AS TREATMENT, A NEW POD WAS APPLIED AT THE HOSPITAL. THE PATIENT WAS DISCHARGED THE SAME DAY. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED HOSPITALIZATION AND HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/23 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMPremature Activation No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED BY THE PATIENT THAT THEY HAD A POD WHERE THE NEEDLE DEPLOYED EARLY BEFORE THE POD WAS APPLIED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/02/06 5:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMInsufficient InformationHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 262 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS ON THE ARM. Manufacturer Narrative: THE SOFT CANNULA WAS FOUND TO BE DAMAGED. THE SOFT CANNULA WAS ALSO MEASURED TO BE ABOVE THE SPECIFICATION. THE DOWNLOAD DATA CONTAINS NO TIMEOUTS, DRIVE STALLS, OR HAZARD ALARMS, INDICATING THERE WAS NO STRUGGLE IN DELIVERING INSULIN. IT COULD NOT BE DETERMINED WHEN AND HOW THE DAMAGE OCCURRED. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/21 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMDifficult to InsertHyperglycemiaEvent Description: IT WAS REPORTED THAT A PATIENT'S BLOOD GLUCOSE (BG) LEVELS REACHED 400 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. DUE TO ELEVATED BG LEVELS, PATIENT SAW THAT THE CANNULA WAS NOT PROPERLY SEATED IN THE INFUSION SITE (ABDOMEN). AS TREATMENT FOR HYPERGLYCEMIA, CORRECTIONS WERE DELIVERED AND A NEW POD WAS APPLIED. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. IT WAS REPORTED THE CANNULA WAS POSSIBLY NOT INSERTED CORRECTLY INTO THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/22 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMFailure to Fire No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED BY THE PATIENT THAT THE CANNULA DID NOT DEPLOY OR INSERT AS INTENDED DURING ACTIVATION. THE PINK SLIDE WAS NOT FORWARD, INDICATING A NEEDLE MECHANISM FAILURE. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/24 4:00:00InjuryINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMInsufficient InformationHyperglycemia; Skin InfectionEvent Description: IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE POD¿S INSERTION SITE (BACK) WHILE WEARING THE DEVICE BETWEEN 24 AND 36 HOURS. THE PATIENT'S BLOOD GLUCOSE ROSE TO 15 MMOL/L (270 MG/DL). THE PATIENT CONTACTED HER GENERAL PRACTITIONER (GP) AND WAS PRESCRIBED FLUCLOXACILLIN 500 MG (4 PER DAY FOR 1 WEEK) AS TREATMENT. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO CUSTOMER'S INFUSION SITE INFECTION. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. THE OMNIPOD IS ISO10993 COMPLIANT, UNDERGOING CYTOTOXICITY, SENSITIZATION, GENOTOXICITY, HEMOLYSIS, IRRITATION OR INTRACUTANEOUS REACTIVITY, SYSTEMIC TOXICITY, AND IMPLANTATION EFFECTS TESTING. THE OMNIPOD IS STERILIZED WITH 100% ETHYLENE OXIDE GAS WITH A STERILITY ASSURANCE LEVEL OF 10-6  PER ISO11135  AND EO RESIDUAL LEVELS IN COMPLIANCE WITH ISO10993. EACH LOT  IS CONFIRMED TO MEET REQUIREMENTS FOR NON-PYROGENICITY PER ISO10993 AND STERILITY PER ISO11135 PRIOR TO RELEASE.
2022/03/22 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMDifficult to InsertHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT¿S BLOOD GLUCOSE LEVEL REACHED 300 MG/DL. THE POD WAS WORN LONGER THAN 48 HOURS. IT WAS NOTED THAT THE PATIENT WAS UNSURE IF THE CANNULA INSERTED PROPERLY INTO THE INFUSION SITE. HYPERGLYCEMIA TREATED WITH A NEW POD. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THE CANNULA WAS POSSIBLY NOT INSERTED CORRECTLY INTO THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/22 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMFailure to Fire No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT THE NEEDLE DID NOT DEPLOY. THE POD WAS WORN LESS THAN AN HOUR. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/22 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMFailure to Fire No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT THE NEEDLE DID NOT DEPLOY. THE POD WAS NOT WORN. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/25 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMFailure to Fire No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT THE NEEDLE DID NOT DEPLOY. THE POD WAS NOT WORN. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/03/25 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMFailure to Fire No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THE PINK SLIDE DID NOT MOVE FORWARD AND THE CANNULA WAS NOT VISIBLE; INDICATING THE NEEDLE MECHANISM DID NOT DEPLOY. THE POD WAS NOT WORN AND NO ADVERSE PATIENT IMPACT WAS REPORTED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/23 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMPremature Activation No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT THE NEEDLE DEPLOYED EARLY. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/03/26 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMPremature Activation No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT THE NEEDLE DEPLOYED EARLY. THE POD WAS NOT WORN. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/02/21 5:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 16 MMOL/L (288 MG/DL). THE POD WAS WORN LESS THAN AN HOUR. IT WAS NOTED THAT THE CANNULA WAS BENT. NO INFORMATION WAS PROVIDED ON HOW THE HYPERGLYCEMIA WAS TREATED. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/02/28 5:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 16 MMOL/L (288 MG/DL). THE POD WAS WORN BETWEEN 1 AND 4 HOURS. IT WAS NOTED THAT THE CANNULA WAS BENT. NO INFORMATION WAS PROVIDED ON HOW THE HYPERGLYCEMIA WAS TREATED. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/25 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 15 MMOL/L (270 MG/DL) WHILE WEARING THE POD BETWEEN 36 AND 48 HOURS. WHEN REMOVED FROM THE INFUSION SITE (ABDOMEN), THE POD'S CANNULA WAS FOUND BENT. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/20 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN PUMPUnintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 414 MG/DL (23 MMOL/L) WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. WHEN REMOVED FROM THE INFUSION SITE (ABDOMEN), THE POD'S CANNULA WAS FOUND TO BE DISLODGED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/21 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 21 MMOL/L (378 MG/DL). THE POD WAS WORN BETWEEN 36 AND 48 HOURS ON THE ABDOMEN. IT WAS NOTED THAT THE CANNULA WAS BENT AND FLUID WAS LEAKING. HYPERGLYCEMIA TREATED WITH A NEW POD AND CORRECTIONAL BOLUS. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/17 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 24.6 MMOL/L (442.8 MG/DL) WITH KETONES OF 1.1. THE POD WAS WORN BETWEEN 4 AND 24 HOURS ON THE ARM. IT WAS NOTED THAT THE CANNULA WAS BENT. HYPERGLYCEMIA TREATED WITH PEN CORRECTION. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/26 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH, PODS 10-PACKFluid Leak; Material Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 17 MMOL/L (306 MG/DL). THE POD WAS LEAKING WHILE WORN FOR BETWEEN 36 AND 48 HOURS. WHEN REMOVED FROM THE INFUSION SITE (LEG), THE POD'S CANNULA WAS FOUND BENT. AS TREATMENT, A NEW POD WAS APPLIED AND A BOLUS WAS DELIVERED. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/04 5:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 17 MMOL/L (306 MG/DL) WHILE WEARING THE POD LONGER THAN 48 HOURS. WHEN REMOVED FROM THE INFUSION SITE (ABDOMEN), THE POD'S CANNULA WAS FOUND BENT. AS TREATMENT, MANUAL INSULIN INJECTIONS WERE DELIVERED. THE POD WAS DISCARDED BY THE PATIENT. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE AVAILABLE FOR INVESTIGATION BECAUSE IT WAS DISCARDED BY THE PATIENT. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/20 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT DESPITE DELIVERING CORRECTIONS, THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 345 MG/DL WHILE WEARING THE POD BETWEEN 36 AND 48 HOURS. WHEN REMOVED FROM THE INFUSION SITE (ARM), THE POD'S CANNULA WAS FOUND BENT. AS TREATMENT, DRANK WATER. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/26 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 303 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. WHEN REMOVED FROM THE INFUSION SITE (ABDOMEN), THE POD'S CANNULA WAS FOUND BENT. AS TREATMENT, A MANUAL INJECTION OF INSULIN WAS GIVEN, A NEW POD WAS APPLIED AND A BOLUS WAS DELIVERED. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/26 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED OVER 400 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. WHEN REMOVED FROM THE INFUSION SITE (LEG), THE POD'S CANNULA WAS FOUND BENT. LARGE KETONES WERE ALSO PRESENT. AS TREATMENT, A NEW POD WAS APPLIED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/26 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 300 MG/DL WHILE WEARING THE POD BETWEEN 36 AND 48 HOURS. WHEN REMOVED FROM THE INFUSION SITE (LEG), THE POD'S CANNULA WAS FOUND BENT. AS TREATMENT, INSULIN WAS DELIVERED. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/16 4:00:00InjuryINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMInsufficient InformationHyperglycemia; Nausea; Vomiting; Diabetic KetoacidosisEvent Description: IT WAS REPORTED BY GRANDMOTHER THAT THE PATIENT HAD BEEN TAKEN TO THE EMERGENCY ROOM (ER) DUE TO DIABETIC KETOACIDOSIS (DKA). THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 545 MG/DL WHILE WEARING THE POD. SYMPTOMS REPORTED INCLUDE HYPERGLYCEMIA, NAUSEA, VOMITING AND PATIENT "HAD ISSUES WITH HER HEART RATE". THE PATIENT WAS TREATED WITH INTRAVENOUS FLUIDS, INSULIN AND ZOFRAN FOR NAUSEA; A CHEST X-RAY WAS PERFORMED AS WELL. THE PATIENT WAS RELEASED FROM THE ER AFTER 6 HOURS. THE POD WAS REMOVED PRIOR TO ER VISIT AND WAS DISCARDED; BRUISING AT THE INFUSION SITE (LEG) WAS ALSO REPORTED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED ER VISIT AND DIABETIC KETOACIDOSIS. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS. HIGH BLOOD GLUCOSE IS A COMMON SYMPTOM FOR PEOPLE WITH DIABETES (GLUCOSE MONITORING DATA FROM PEOPLE WITH DIABETES INDICATE THAT ON AVERAGE, THEY CAN EXPERIENCE BLOOD GLUCOSE LEVELS ABOVE 250 MG/DL FOR 14-25% OF THE TIME[1][2][3]), AND IT WOULD BE CHALLENGING TO SPECULATE ON A CAUSE FOR THE COMPLAINTS WITHOUT RECEIVING THE DEVICES BACK FOR AN ENGINEERING INVESTIGATION. BECK RW, BERGENSTAL RM, CHENG P, KOLLMAN C, CARLSON AL, JOHNSON ML, RODBARD D. THE RELATIONSHIPS BETWEEN TIME IN RANGE, HYPERGLYCEMIA METRICS, AND HBA1C. J DIABETES SCI TECHNOL 2019;13:614-626. WELSH JB, DERDZINSKI M, PARKER AS, PUHR S, JIMENEZ A, WALKER T. REAL-TIME SHARING AND FOLLOWING OF CONTINUOUS GLUCOSE MONITORING DATA IN YOUTH. DIABETES THER 2019;10:751-755. PUHR S, DERDZINSKI M, WELSH JB, PARKER AS, WALKER T, PRICE DA. REAL-WORLD HYPOGLYCEMIA AVOIDANCE WITH A CONTINUOUS GLUCOSE MONITORING SYSTEM'S PREDICTIVE LOW GLUCOSE ALERT. DIABETES TECHNOL THER 2019;21:155-158.
2022/03/17 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM Activation, Positioning or SeparationProblem No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED A PATIENT HAD A POD IN WHICH THE PINK SLIDE DID NOT MOVE FORWARD WHEN THE POD WAS ACTIVATED; THIS INDICATES A NEEDLE MECHANISM FAILURE OCCURRED. AS TREATMENT, THE PATIENT APPLIED A NEW POD. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/16 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMFluid Leak; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE ABOVE 458 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. THE POD WAS LEAKING INSULIN FROM THE INFUSION SITE (LEG), CAUSING THE CANNULA TO DISLODGE. AS TREATMENT, A NEW POD WAS APPLIED. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/10 5:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE ABOVE 20 MMOL/L (>360 MG/DL) WHILE WEARING THE POD LONGER THAN 48 HOURS. WHEN REMOVED FROM THE INFUSION SITE (LEG), THE POD'S CANNULA WAS FOUND BENT. AS TREATMENT, MANUAL INSULIN INJECTIONS WERE DELIVERED. THE POD WAS DISCARDED BY THE PATIENT. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE AVAILABLE FOR INVESTIGATION BECAUSE IT WAS DISCARDED BY THE PATIENT. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/16 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) ROSE TO 260 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. THE POD REPORTEDLY FELL OFF THE INFUSION SITE (HIP/BUTTOCKS), CAUSING THE CANNULA TO DISLODGE. AS TREATMENT, A NEW POD WAS APPLIED. THE POD WAS DISCARDED. THE PATIENT'S BLOOD GLUCOSE, CARBOHYDRATE, AND INSULIN HISTORY ARE AS FOLLOWS: (B)(6). Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/17 4:00:00InjuryINSULET CORPORATIONOMNIPOD INSULIN PUMPInsufficient InformationHypoglycemia; Loss of consciousnessEvent Description: IT WAS REPORTED THAT THE PATIENT REQUIRED MEDICAL INTERVENTION DUE TO HYPOGLYCEMIA WHILE WEARING A POD. PATIENT LOST CONSCIOUSNESS WHILE ON AN INTERNATIONAL FLIGHT; SHE WAS TREATED WITH GLUCAGON AND SOLU-CORTEF BY DOCTORS ON BOARD (OR FLIGHT PERSONNEL). PATIENT REGAINED CONSCIOUSNESS AFTER 40 MINUTES. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED MEDICAL INTERVENTION AND HYPOGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/03/17 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) ROSE TO 333 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. THE POD REPORTEDLY FELL OFF THE INFUSION SITE (ARM), CAUSING THE CANNULA TO DISLODGE. IT WAS ALSO STATED THAT THE ADHESIVE WAS LIFTED UP. AS TREATMENT, THE PATIENT SUCCESSFULLY ACTIVATED A NEW POD. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/16 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) ROSE TO OVER 400 MG/DL WHILE WEARING THE POD FOR LESS THAN AN HOUR. THE POD REPORTEDLY FELL OFF THE INFUSION SITE (ARM), CAUSING THE CANNULA TO DISLODGE. DETAILS REGARDING TREATMENT WERE NOT PROVIDED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/17 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) ROSE TO OVER 400 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. THE POD REPORTEDLY FELL OFF THE INFUSION SITE (ARM), CAUSING THE CANNULA TO DISLODGE. DETAILS REGARDING TREATMENT WERE NOT PROVIDED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/16 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) ROSE TO OVER 400 MG/DL WHILE WEARING THE POD FOR LESS THAN AN HOUR. THE POD REPORTEDLY FELL OFF THE INFUSION SITE (ARM), CAUSING THE CANNULA TO DISLODGE. DETAILS REGARDING TREATMENT WERE NOT PROVIDED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/18 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) ROSE TO AROUND 250-300 MG/DL WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. THE POD REPORTEDLY FELL OFF THE INFUSION SITE (ARM), CAUSING THE CANNULA TO DISLODGE. AS TREATMENT, A NEW POD WAS APPLIED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/26 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMUnintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED OVER 250 MG/DL WHILE WEARING THE POD. PATIENT STATED THE CANNULA DISLODGED FROM THE INFUSION SITE. ADDITIONAL METHOD OF TREATMENT WAS NOT PROVIDED. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/13 5:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE ABOVE 20 MMOL/L (>360 MG/DL) WHILE WEARING THE POD LONGER THAN 48 HOURS. WHEN REMOVED FROM THE INFUSION SITE (LEG), THE POD'S CANNULA WAS FOUND BENT. AS TREATMENT, MANUAL INSULIN INJECTIONS WERE DELIVERED. THE POD WAS DISCARDED BY THE PATIENT. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE AVAILABLE FOR INVESTIGATION BECAUSE IT WAS DISCARDED BY THE PATIENT. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/05 5:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 400 MG/DL WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. WHEN REMOVED FROM THE INFUSION SITE (LEG), THE POD'S CANNULA WAS FOUND BENT. AS TREATMENT, A NEW POD WAS PLACED. THE POD WAS DISCARDED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/03/20 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 468 MG/DL WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. WHEN REMOVED FROM THE INFUSION SITE (HIP/BUTTOCKS), THE POD'S CANNULA WAS FOUND TO BE DISLODGED. AS TREATMENT, A NEW POD WAS APPLIED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/19 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 352 MG/DL WHILE WEARING THE POD BETWEEN 36 AND 48 HOURS. WHEN REMOVED FROM THE INFUSION SITE (LEG), THE POD'S CANNULA WAS FOUND BENT. DETAILS REGARDING TREATMENT WERE NOT PROVIDED. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/19 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) ROSE TO OVER 300 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. THE POD REPORTEDLY WAS COMING LOOSE FROM THE INFUSION SITE (ARM), CAUSING THE CANNULA TO DISLODGE. AS TREATMENT THE PATIENT REPLACED THE POD. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/02/22 5:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMInsufficient InformationHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED AROUND 400 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS ON THE HIP/BUTTOCKS. AS TREATMENT, A NEW POD WAS APPLIED. Manufacturer Narrative: THE DEVICE WAS RECEIVED FULLY DEPLOYED. THE DOWNLOAD DATA SHOWED NO TIMEOUTS, DRIVE STALLS OR ALARMS THAT WOULD INDICATE A FAILURE OF THE DEVICE TO DELIVER INSULIN. THE DISTAL TIP OF THE SOFT CANNULA WAS OBSERVED TO BE DAMAGED. THE LENGTH OF THE SOFT CANNULA WAS MEASURED OUT OF SPECIFICATIONS. BECAUSE THE CANNULA WAS DAMAGED, FLUID WAS NOT ABLE TO EXIT THE ENTIRE FLUID PATH AS INTENDED. IT CAN NOT BE DETERMINED WHEN THE DAMAGE OCCURRED OR IF IT CONTRIBUTED TO THE REPORTED EVENT. DURING INSPECTION OF THE FLUID PATH, DEBRIS WAS FOUND IN THE RESERVOIR. IT CANNOT BE DETERMINED IF THIS DEBRIS CONTRIBUTED TO THE REPORTED EVENT. NO OTHER DAMAGES OR DEFICIENCIES WERE OBSERVED DURING THE INVESTIGATION. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2021/12/21 5:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMInsufficient InformationHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED OVER 350 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS ON THE LEG. AS TREATMENT, POD WAS REMOVED AND A MANUAL INJECTION OF INSULIN WAS DELIVERED. Manufacturer Narrative: THE SOFT CANNULA LEAKED INSULIN THROUGH A TEAR IN ITS UNEXPOSED PORTION, REDUCING THE INSULIN REACHING THE CLIENT, RESULTING IN THE REPORTED INSULIN DELIVERY FAILURE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/21 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) ROSE TO 275 MG/DL WHILE WEARING THE POD LESS THAN AN HOUR. THE POD REPORTEDLY FELL OFF THE INFUSION SITE (ARM), CAUSING THE CANNULA TO DISLODGE. AS TREATMENT, THE PATIENT WAS WAITING FOR HER DAUGHTER TO HELP THEM. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/21 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMRetraction ProblemBruise/Contusion; PainEvent Description: IT WAS REPORTED THAT THE NEEDLE MECHANISM DID NOT RETRACT AS INTENDED. THE PATIENT EXPERIENCED PAIN AND BLEEDING FROM THE INFUSION SITE. THIS INDICATES A NEEDLE MECHANISM FAILURE. THE POD WAS WORN FOR LESS THAN AN HOUR. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/18 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) ROSE TO 400 MG/DL WHILE WEARING THE POD BETWEEN 36 AND 48 HOURS. THE PODS CANNULA REPORTEDLY WAS OUT OF THE ADHESIVE (ABDOMEN), CAUSING THE CANNULA TO DISLODGE. AS TREATMENT, THE PATIENTS MOTHER SUCCESSFULLY ACTIVATED A NEW POD. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/20 4:00:00InjuryINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentDehydration; Headache; HyperglycemiaEvent Description: IT WAS REPORTED BY FATHER THAT THE PATIENT HAD BEEN HOSPITALIZED WITH HYPERGLYCEMIA. DESPITE GIVING HIMSELF 27 UNITS OF INSULIN, THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED AROUND 403 MG/DL WHILE WEARING THE POD BETWEEN 1 AND 4 HOURS. SYMPTOMS REPORTED INCLUDE LARGE KETONES, LETHARGY, DEHYDRATION AND A HEADACHE. THE PATIENT WAS TREATED WITH INTRAVENOUS FLUIDS, AN INSULIN DRIP AND ANTI-NAUSEA MEDICATION. THE PATIENT REMAINED IN THE HOSPITAL FOR THE SECOND DAY AT THE TIME OF REPORTING. THE POD WAS REMOVED AT THE HOSPITAL; UPON REMOVAL, THE CANNULA APPEARED BENT. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED HOSPITALIZATION AND HYPERGLYCEMIA. WE ARE ALSO UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS. ADDITIONALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/20 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMPremature Activation No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT THE NEEDLE DEPLOYED PRIOR TO PROPER POD ACTIVATION. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/17 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE ABOVE 20 MMOL/L (>360 MG/DL) WHILE WEARING THE POD FOR BETWEEN 24 AND 36 HOURS. WHEN REMOVED FROM THE INFUSION SITE (ABDOMEN), THE POD'S CANNULA WAS FOUND BENT. AS TREATMENT, MANUAL INSULIN INJECTIONS WERE DELIVERED. THE POD WAS DISCARDED BY THE PATIENT. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE AVAILABLE FOR INVESTIGATION BECAUSE IT WAS DISCARDED BY THE PATIENT. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/22 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMFailure to Fire No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED BY THE PATIENT THAT THE CANNULA DID NOT DEPLOY. THE PINK SLIDE DID NOT MOVE FORWARD AND CANNULA WAS NOT VISIBLE. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/22 4:00:00InjuryINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentDehydration; Hyperglycemia; Nausea; Pain; Vomiting; Diabetic KetoacidosisEvent Description: IT WAS REPORTED THAT THE PATIENT SOUGHT MEDICAL ATTENTION WITH HYPERGLYCEMIA. THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 400 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. SYMPTOMS REPORTED INCLUDE PAIN IN STOMACH, NAUSEA AND VOMITING. AT THE HOSPITAL THE PATIENT WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS. THE PATIENT WAS TREATED WITH IV (INTRAVENOUS) FLUID FOR BEING DEHYDRATED, ZOFRAN IV (INTRAVENOUS) TO HELP WITH NAUSEA AND THEN STARTED HIM ON IV (INTRAVENOUS) INSULIN TO TREAT. THE PATIENT WAS RELEASED THAT SAME DAY. THE POD WAS REMOVED BEFORE THE PATIENT WENT TO THE HOSPITAL. ONCE THE POD WAS REMOVED IT WAS NOTED THAT THE CANNULA WAS BENT. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED HOSPITALIZATION AND HYPERGLYCEMIA. WE ARE ALSO UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED HOSPITALIZATION AND DIABETIC KETOACIDOSIS. LASTLY, WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE AND FREEDOM FROM HAZARD ALARMS.
2022/03/22 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMFailure to Fire No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED BY THE PATIENT THAT THE CANNULA DID NOT INSERT INTO THE SKIN. THE CANNULA WAS NOT VISIBLE. THE POD WAS WORN FOR LESS THAN AN HOUR. AS TREATMENT, THE POD WAS REMOVED RIGHT AWAY. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/22 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMFailure to Fire No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED BY THE PATIENT THAT THE NEEDLE DID NOT COME OUT OF THE POD. THE PINK SLIDE DID NOT MOVE FORWARD. AS TREATMENT, THE PATIENT CHANGED THE POD RIGHT AWAY. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/25 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMRetraction Problem No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT THE NEEDLE DID NOT RETRACT WHEN THE POD WAS ACTIVATED; THIS INDICATES A NEEDLE MECHANISM FAILURE OCCURRED. THE POD WAS NOT WORN. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/25 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMPremature Activation No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT THE NEEDLE DEPLOYED EARLY WHEN THE POD WAS ACTIVATED; THIS INDICATES A NEEDLE MECHANISM FAILURE OCCURRED. THE POD WAS NOT WORN. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/26 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMPremature ActivationHyperglycemiaEvent Description: IT WAS REPORTED THAT THE NEEDLE DEPLOYED EARLY WHEN THE POD WAS ACTIVATED; THIS INDICATES A NEEDLE MECHANISM FAILURE OCCURRED. THE POD WAS NOT WORN AND PATIENT REPORTED A BLOOD GLUCOSE LEVEL OF 400 MG/DL. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/22 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM Activation, Positioning or SeparationProblem No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED BY THE PATIENT THAT THE PINK SLIDE DID NOT MOVE FORWARD INDICATING A NEEDLE MECHANISM FAILURE. THE POD WAS WORN FOR LONGER THAN 48 HOURS. AS TREATMENT, THE PATIENT WILL BE TAKING SYRINGE SHOTS. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/25 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMPremature Activation No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT THE NEEDLE DEPLOYED EARLY WHEN THE POD WAS ACTIVATED; THIS INDICATES A NEEDLE MECHANISM FAILURE OCCURRED. THE POD WAS NOT WORN. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/22 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMPremature ActivationHyperglycemiaEvent Description: IT WAS REPORTED BY THE PATIENT THAT THE CANNULA CAME OUT OF THE POD. THE BLOOD GLUCOSE LEVELS WERE AT 400 MG/DL AND THE POD WAS NOT WORN. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/22 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMFailure to Fire No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED BY THE PATIENT THAT THE CANNULA DID NOT DEPLOY OR INSERT AS INTENDED DURING ACTIVATION. THE PINK SLIDE WAS NOT FORWARD, INDICATING A NEEDLE MECHANISM FAILURE. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/26 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMDifficult or Delayed Activation No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT THE NEEDLE DEPLOYED LATE WHEN THE POD WAS ACTIVATED; THIS INDICATES A NEEDLE MECHANISM FAILURE OCCURRED. THE POD WAS NOT WORN. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/26 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMFailure to Fire No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT THE CANNULA DID NOT DEPLOY WHEN THE POD WAS ACTIVATED; THIS INDICATES A NEEDLE MECHANISM FAILURE OCCURRED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/03/18 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN PUMP Activation, Positioning or SeparationProblemHyperglycemiaEvent Description: IT WAS REPORTED BY THE PATIENT THAT THE PINK SLIDE DID NOT MOVE FORWARD INDICATING A NEEDLE MECHANISM FAILURE. THE BLOOD GLUCOSE LEVELS REACH TO 372 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. AS TREATMENT, THE PATIENT GAVE CORRECTIONS WITH THE PDM. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/01/21 5:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMInsufficient InformationHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE (BG) LEVELS REACHED 339 MG/DL, WHILE WEARING THE POD ON THE LEG BETWEEN 36 AND 48 HOURS. A NEW POD WAS APPLIED TO TREAT THE HYPERGLYCEMIA. Manufacturer Narrative: THE SOFT CANNULA WAS FOUND TO BE DAMAGED. THE DOWNLOAD DATA CONTAINS NO TIMEOUTS, DRIVE STALLS, OR HAZARD ALARMS, INDICATING THERE WAS NO STRUGGLE IN DELIVERING INSULIN. IT COULD NOT BE DETERMINED HOW AND WHEN THE CANNULA WAS DAMAGED. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/16 4:00:00InjuryINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMInsufficient InformationBurn(s); Skin InfectionEvent Description: IT WAS REPORTED BY THE PATIENT THAT THEY HAVE THIRD DEGREE BURNS DUE TO THE ADHESIVE OF THIS POD. THE POD WAS WORN BETWEEN 4 AND 24 HOURS ON THE SITE(LEG). IT WAS ALSO REPORTED THAT THE PATIENT BELIEVED THE SITE WAS INFECTED, PUSSING AND BURNING. THIS ISSUE HAS NOT BEEN DIAGNOSED BY A HEALTH CARE PROVIDER AND DID NOT SEEK MEDICAL ATTENTION. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO 3RD DEGREE BURNS ON SKIN. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. THE OMNIPOD IS ISO10993 COMPLIANT, UNDERGOING CYTOTOXICITY, SENSITIZATION, GENOTOXICITY, HEMOLYSIS, IRRITATION OR INTRACUTANEOUS REACTIVITY, SYSTEMIC TOXICITY, AND IMPLANTATION EFFECTS TESTING. THE OMNIPOD IS STERILIZED WITH 100% ETHYLENE OXIDE GAS WITH A STERILITY ASSURANCE LEVEL OF 10-6  PER ISO11135  AND EO RESIDUAL LEVELS IN COMPLIANCE WITH ISO10993. EACH LOT  IS CONFIRMED TO MEET REQUIREMENTS FOR NON-PYROGENICITY PER ISO10993 AND STERILITY PER ISO11135 PRIOR TO RELEASE.
2022/03/25 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMDifficult to InsertHyperglycemiaEvent Description: IT WAS REPORTED THAT A PATIENT'S BLOOD GLUCOSE LEVELS (BG) REACHED 300 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. THE PATIENT REPORTED BEING UNSURE IF THE CANNULA WAS PROPERLY SEATED WHILE WEARING IT ON THE LEG. FOR TREATMENT, MANUAL INJECTION WAS ADMINISTERED. THE POD WAS DISCARDED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THE CANNULA WAS POSSIBLY NOT INSERTED CORRECTLY INTO THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/25 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMDifficult to InsertHyperglycemiaEvent Description: IT WAS REPORTED THAT A PATIENT'S BLOOD GLUCOSE LEVELS (BG) REACHED 300 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. THE PATIENT REPORTED BEING UNSURE IF THE CANNULA WAS PROPERLY SEATED WHILE WEARING IT ON THE ARM. FOR TREATMENT, MANUAL INJECTION WAS ADMINISTERED. THE POD WAS DISCARDED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THE CANNULA WAS POSSIBLY NOT INSERTED CORRECTLY INTO THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/25 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMDifficult to InsertHyperglycemiaEvent Description: IT WAS REPORTED THAT A PATIENT'S BLOOD GLUCOSE LEVELS (BG) REACHED 300 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. THE PATIENT REPORTED BEING UNSURE IF THE CANNULA WAS PROPERLY SEATED WHILE WEARING IT ON THE ARM. FOR TREATMENT, MANUAL INJECTION WAS ADMINISTERED. THE POD WAS DISCARDED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THE CANNULA WAS POSSIBLY NOT INSERTED CORRECTLY INTO THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/01/19 5:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMInsufficient InformationHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE (BG) LEVELS REACHED 320 MG/DL, WHILE WEARING THE POD ON THE ABDOMEN LONGER THAN 48 HOURS. A MANUAL INSULIN INJECTION WAS ADMINISTERED TO TREAT THE HYPERGLYCEMIA. Manufacturer Narrative: A TEAR WAS OBSERVED ON THE EXPOSED PORTION OF THE SOFT CANNULA. FLUID WAS OBSERVED LEAKING THROUGH THE TEAR DURING FLUID PATH TESTING. THE DOWNLOADED DATA DID NOT SHOW ANY TIMEOUTS OR DRIVE STALLS THAT COULD INDICATE A FAILURE OF THE DEVICE TO DELIVER INSULIN. ALTHOUGH DAMAGE WAS OBSERVED ON THE EXPOSED PORTION OF THE SOFT CANNULA, THE TIMING AND CAUSE COULD NOT BE DETERMINED. NO OTHER DAMAGES OR DEFECTS WERE OBSERVED WITH THE DEVICE THAT COULD AFFECT INSULIN DELIVERY. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/25 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMDifficult to InsertHyperglycemiaEvent Description: IT WAS REPORTED THAT A PATIENT'S BLOOD GLUCOSE LEVELS (BG) REACHED 300 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. THE PATIENT REPORTED BEING UNSURE IF THE CANNULA WAS PROPERLY SEATED WHILE WEARING IT ON THE ARM. FOR TREATMENT, MANUAL INJECTION WAS ADMINISTERED. THE POD WAS DISCARDED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THE CANNULA WAS POSSIBLY NOT INSERTED CORRECTLY INTO THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/22 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMFluid Leak; Material Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 350 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. WHEN REMOVED FROM THE INFUSION SITE (ABDOMEN), THE POD'S CANNULA WAS FOUND BENT. IN ADDITION THE POD WAS LEAKING DURING WEAR AND THE PATIENT HAD A BUMP AT THE POD INFUSION SITE. THE POD WILL NOT BE RETURNED AS IT HAS BEEN DISCARDED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/01/28 5:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMInsufficient InformationHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE (BG) LEVELS REACHED 500 MG/DL, WHILE WEARING THE POD ON THE ARM BETWEEN 36 AND 48 HOURS. A NEW POD WAS APPLIED TO TREAT THE HYPERGLYCEMIA. Manufacturer Narrative: DEVICE WAS RECEIVED FULLY DEPLOYED. CORROSION WAS VISIBLE THROUGH THE TOP HOUSING AND ON THE PCB. AFTER POD OPENING, CORROSION WAS SEEN ON HARD CANNULA, LINKAGE ASSEMBLY, COMMUTATOR CAP, TOP RATCHET GEAR RETAINER PIN, MECHANISM RAILS, CATCH BEAM AND BOTTOM BATTERY. THE VOLTAGE ON BOTTOM BATTERY AND MIDDLE BATTERY MEASURED LOWER THAN EXPECTED. THEREFORE, BY PROVIDING EXTERNAL POWER TO THE DEVICE, THE DATA FROM DEVICE WAS ABLE TO BE DOWNLOADED. THE DATA SHOWED NO ABNORMALITIES. FLUID PATH TEST WAS PERFORMED, AND FLUID INITIALLY FLOWED THROUGH THE FLUID PATH. A LEAK TEST WAS PERFORMED BY MANUALLY OCCLUDING THE DISTAL TIP OF THE SOFT CANNULA. UPON MANUALLY ROTATING THE RATCHET GEAR, FLUID WAS OBSERVED TO BE LEAKING FROM AN INTERNAL TEAR. THE INTERNAL TEAR CAUSED FLUID DEPOSITION INSIDE THE POD LEADING TO CORROSION. FLUID LEAKING FROM THE INTENDED FLUID PATH RESULTED IN IMPROPER INSULIN DELIVERY. A CRACK WAS OBSERVED IN THE TOP HOUSING OF THE POD. IT COULD NOT BE DETERMINED WHEN THIS CRACK OCCURRED. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/25 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMDifficult to InsertHyperglycemiaEvent Description: IT WAS REPORTED THAT A PATIENT'S BLOOD GLUCOSE LEVELS (BG) REACHED 300 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. THE PATIENT REPORTED BEING UNSURE IF THE CANNULA WAS PROPERLY SEATED WHILE WEARING IT ON THE ARM. FOR TREATMENT, MANUAL INJECTION WAS ADMINISTERED. THE POD WAS DISCARDED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THE CANNULA WAS POSSIBLY NOT INSERTED CORRECTLY INTO THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/17 4:00:00InjuryINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMInsufficient InformationHyperglycemia; NauseaEvent Description: IT WAS REPORTED THAT THE PATIENT HAD BEEN HOSPITALIZED WITH HYPERGLYCEMIA. THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 500+ MG/DL WHILE WEARING THE POD LONGER THAN 48 HOURS. SYMPTOMS REPORTED INCLUDE NAUSEA. THE PATIENT WAS TREATED WITH A INSULIN DRIP, FOR 1-2 HOUR INTERVALS, WITH SALINE. THE HOSPITAL GAVE POTASSIUM AND AMLODIPINE MEDICATION TO PREVENT PROTEIN BUILDUP AND IS NORMALLY FOR HIGH BLOOD PRESSURE. THE PATIENT WAS RELEASED THE AFTER 3 DAYS. THE POD WAS DEACTIVATED ONCE IN HIS HOSPITAL ROOM, AND REMOVED IT MUCH LATER HIMSELF. THE POD WAS DISCARDED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED HOSPITALIZATION AND HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS. HIGH BLOOD GLUCOSE IS A COMMON SYMPTOM FOR PEOPLE WITH DIABETES (GLUCOSE MONITORING DATA FROM PEOPLE WITH DIABETES INDICATE THAT ON AVERAGE, THEY CAN EXPERIENCE BLOOD GLUCOSE LEVELS ABOVE 250 MG/DL FOR 14-25% OF THE TIME[1][2][3]), AND IT WOULD BE CHALLENGING TO SPECULATE ON A CAUSE FOR THE COMPLAINTS WITHOUT RECEIVING THE DEVICES BACK FOR AN ENGINEERING INVESTIGATION. BECK RW, BERGENSTAL RM, CHENG P, KOLLMAN C, CARLSON AL, JOHNSON ML, RODBARD D. THE RELATIONSHIPS BETWEEN TIME IN RANGE, HYPERGLYCEMIA METRICS, AND HBA1C. J DIABETES SCI TECHNOL 2019;13:614-626. WELSH JB, DERDZINSKI M, PARKER AS, PUHR S, JIMENEZ A, WALKER T. REAL-TIME SHARING AND FOLLOWING OF CONTINUOUS GLUCOSE MONITORING DATA IN YOUTH. DIABETES THER 2019;10:751-755. PUHR S, DERDZINSKI M, WELSH JB, PARKER AS, WALKER T, PRICE DA. REAL-WORLD HYPOGLYCEMIA AVOIDANCE WITH A CONTINUOUS GLUCOSE MONITORING SYSTEM'S PREDICTIVE LOW GLUCOSE ALERT. DIABETES TECHNOL THER 2019;21:155-158".
2022/03/14 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMFluid Leak; Material Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 350 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. WHEN REMOVED FROM THE INFUSION SITE (ABDOMEN), THE POD'S CANNULA WAS FOUND BENT. IT WAS ALSO STATED THAT THEY COULD SMELL AND FEEL INSULIN. AS TREATMENT, THE PATIENT CHANGED THE POD. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/22 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMFluid Leak; Material Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 350 MG/DL WHILE WEARING THE POD BETWEEN 36 AND 48 HOURS. WHEN REMOVED FROM THE INFUSION SITE (ABDOMEN), THE POD'S CANNULA WAS FOUND BENT. IN ADDITION THE POD WAS LEAKING DURING WEAR. AS TREATMENT, THE PATIENT APPLIED A NEW POD. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/23 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMPremature Activation No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED BY THE PATIENT THAT THE CANNULA DEPLOYED EARLIER THAN EXPECTED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/16 4:00:00InjuryINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMInsufficient InformationDehydration; Fatigue; Hyperglycemia; Nausea; Pain; Vomiting; Diabetic KetoacidosisEvent Description: IT WAS REPORTED THAT THE PATIENT HAD BEEN TAKEN BY AMBULANCE AND HOSPITALIZED IN THE INTENSIVE CARE UNIT WITH DIABETIC KETOACIDOSIS (DKA). THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 454 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. SYMPTOMS REPORTED INCLUDE HYPERGLYCEMIA, VOMITING BLOOD, NAUSEA, ABDOMINAL PAIN, FATIGUE, WEAKNESS AND DEHYDRATION; PATIENT ALSO LAD LOW POTASSIUM AND STATED HER BICARBONATE WAS OFF. THE POD WAS REMOVED AND PATIENT WAS TREATED WITH INSULIN AND FLUIDS DRIPS AND ELECTROLYTES; A SCOPOLAMINE PATCH WAS ALSO APPLIED FOR NAUSEA AND PATIENT WAS LATER GIVEN A PRESCRIPTION FOR THESE PATCHES UPON HOSPITAL RELEASE. PATIENT WAS RELEASED AFTER SPENDING 4 DAYS IN THE ICU. THE PATIENT'S BLOOD GLUCOSE HISTORY IS AS FOLLOWS: TIME: 1:00AM, 6:00AM, 9:00AM , 11:00AM , 8:30PM. 3:40PM, BG(MG/DL): 454, 439, 253, 278, 262, 285. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED HOSPITALIZATION AND DIABETIC KETOACIDOSIS. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS. HIGH BLOOD GLUCOSE IS A COMMON SYMPTOM FOR PEOPLE WITH DIABETES (GLUCOSE MONITORING DATA FROM PEOPLE WITH DIABETES INDICATE THAT ON AVERAGE, THEY CAN EXPERIENCE BLOOD GLUCOSE LEVELS ABOVE 250 MG/DL FOR 14-25% OF THE TIME[1][2][3]..), AND IT WOULD BE CHALLENGING TO SPECULATE ON A CAUSE FOR THE COMPLAINTS WITHOUT RECEIVING THE DEVICES BACK FOR AN ENGINEERING INVESTIGATION. [1] BECK RW, BERGENSTAL RM, CHENG P, KOLLMAN C, CARLSON AL, JOHNSON ML, RODBARD D. THE RELATIONSHIPS BETWEEN TIME IN RANGE, HYPERGLYCEMIA METRICS, AND HBA1C. J DIABETES SCI TECHNOL 2019;13:614-626. [1] WELSH JB, DERDZINSKI M, PARKER AS, PUHR S, JIMENEZ A, WALKER T. REAL-TIME SHARING AND FOLLOWING OF CONTINUOUS GLUCOSE MONITORING DATA IN YOUTH. DIABETES THER 2019;10:751-755. [1] PUHR S, DERDZINSKI M, WELSH JB, PARKER AS, WALKER T, PRICE DA. REAL-WORLD HYPOGLYCEMIA AVOIDANCE WITH A CONTINUOUS GLUCOSE MONITORING SYSTEM'S PREDICTIVE LOW GLUCOSE ALERT. DIABETES TECHNOL THER 2019;21:155-158.
2022/03/08 5:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMFluid Leak; Material Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO OVER 250 MG/DL WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. WHEN REMOVED FROM THE INFUSION SITE (ARM), THE POD'S CANNULA WAS FOUND BENT. IN ADDITION THE POD WAS LEAKING DURING WEAR. AS TREATMENT, THE PATIENT APPLIED A NEW POD. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/23 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMUnintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 350 MG/DL WHILE WEARING THE POD. THE PATIENT REPORTS THE PODS CANNULA HAD BECOME DISLODGED FROM THE POD INFUSION SITE. AS TREATMENT, THE PATIENT ADMINISTERED INSULIN VIA PEN INJECTION AND APPLIED A NEW POD. THE POD WILL NOT BE RETURNED AS IT HAS BEEN DISCARDED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/23 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Fluid Leak; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO OVER 400 MG/DL WHILE WEARING THE POD BETWEEN 36 AND 48 HOURS. IT WAS REPORTED WHILE THE PATIENT HAD BENT OVER THE PODS CANNULA HAD BECOME DISLODGED FROM THE POD INFUSION SITE (ABDOMEN). IN ADDITION THE PODS ADHESIVE WAS LOOSE AND THE POD WAS LEAKING DURING WEAR. AS TREATMENT, THE PATIENT ADMINISTERED A MANUAL SHOT OF INSULIN AND APPLIED A NEW POD. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/22 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMUnintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 350 MG/DL WHILE WEARING THE POD FOR LONGER THAN 48 HOURS. THE PATIENT REPORTS THE PODS CANNULA HAD BECOME DISLODGED FROM THE POD INFUSION SITE (ABDOMEN). AS TREATMENT, THE PATIENT ADMINISTERED INSULIN VIA PEN INJECTION AND APPLIED A NEW POD. THE POD WILL NOT BE RETURNED AS IT HAS BEEN DISCARDED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/23 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMUnintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 350 MG/DL WHILE WEARING THE POD. THE PATIENT REPORTS THE PODS CANNULA HAD BECOME DISLODGED FROM THE POD INFUSION SITE. AS TREATMENT, THE PATIENT ADMINISTERED INSULIN VIA PEN INJECTION AND APPLIED A NEW POD. THE POD WILL NOT BE RETURNED AS IT HAS BEEN DISCARDED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/22 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMDifficult to InsertHyperglycemia; PainEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO OVER 300 MG/DL WHILE WEARING THE POD FOR LESS THAN AN HOUR. THE PATIENT REPORTED BEING UNSURE IF THE CANNULA WAS PROPERLY SEATED IN THE INFUSION SITE (ARM). IN ADDITION THE PATIENT EXPERIENCED PAIN AT THE POD INFUSION SITE. AS TREATMENT, THE PATIENT ADMINISTERED A SHOT OF MANUAL INSULIN. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THE CANNULA WAS POSSIBLY NOT INSERTED CORRECTLY INTO THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/22 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMDifficult to InsertHyperglycemia; PainEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO OVER 300 MG/DL WHILE WEARING THE POD FOR LESS THAN AN HOUR. THE PATIENT REPORTED BEING UNSURE IF THE CANNULA WAS PROPERLY SEATED IN THE INFUSION SITE (LEG). IN ADDITION THE PATIENT EXPERIENCED PAIN AT THE POD INFUSION SITE. AS TREATMENT, THE PATIENT ADMINISTERED A SHOT OF MANUAL INSULIN. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THE CANNULA WAS POSSIBLY NOT INSERTED CORRECTLY INTO THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/23 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 420 MG/DL WHILE WEARING THE POD BETWEEN 1 AND 4 HOURS. WHEN REMOVED FROM THE INFUSION SITE (ARM), THE POD'S CANNULA WAS FOUND BENT. AS TREATMENT, THE PATIENT ADMINISTERED A MANUAL INJECTION OF INSULIN AND APPLIED A NEW POD. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/23 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMDifficult to InsertHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT¿S BLOOD GLUCOSE LEVEL REACHED 25.2 MMOL/L (453.6 MG/DL). THE POD WAS WORN BETWEEN 4 AND 24 HOURS ON THE LEG. IT WAS NOTED THAT THE PATIENT WAS UNSURE IF THE CANNULA INSERTED PROPERLY INTO THE INFUSION SITE. HYPERGLYCEMIA TREATED WITH CORRECTIONAL BOLUS AND A NEW POD. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. IT WAS REPORTED THE CANNULA WAS POSSIBLY NOT INSERTED CORRECTLY INTO THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/24 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 20 MMOL/L (360 MG/DL). THE POD WAS WORN BETWEEN 36 AND 48 HOURS. IT WAS NOTED THAT THE CANNULA WAS BENT. NO INFORMATION WAS PROVIDED ON HOW THE HYPERGLYCEMIA WAS TREATED. DEVICE WAS DISCARDED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/03/17 4:00:00InjuryINSULET CORPORATIONOMNIPOD INSULIN PUMPMaterial Twisted/BentHyperglycemia; Diabetic KetoacidosisEvent Description: IT WAS REPORTED THAT A PATIENT HAD BEEN HOSPITALIZED WITH DIABETIC KETOACIDOSIS (DKA). IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 700 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS ON THE LEG. THE PATIENT WAS TREATED WITH INTRAVENOUS THERAPY WITH AN INULIN DRIP. THEY SAW THAT THE CANNULA WAS BENT UPON REMOVAL OF THE POD. THE PATIENT WAS RELEASED THE FOLLOWING DAY. THE POD WAS REMOVED AND DISCARDED AT THE HOSPITAL. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA AND HOSPITALIZATION WITH DKA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS. "HIGH BLOOD GLUCOSE IS A COMMON SYMPTOM FOR PEOPLE WITH DIABETES (GLUCOSE MONITORING DATA FROM PEOPLE WITH DIABETES INDICATE THAT ON AVERAGE, THEY CAN EXPERIENCE BLOOD GLUCOSE LEVELS ABOVE 250 MG/DL FOR 14-25% OF THE TIME.), AND IT WOULD BE CHALLENGING TO SPECULATE ON A CAUSE FOR THE COMPLAINTS WITHOUT RECEIVING THE DEVICES BACK FOR AN ENGINEERING INVESTIGATION. BECK RW, BERGENSTAL RM, CHENG P, KOLLMAN C, CARLSON AL, JOHNSON ML, RODBARD D. THE RELATIONSHIPS BETWEEN TIME IN RANGE, HYPERGLYCEMIA METRICS, AND HBA1C. J DIABETES SCI TECHNOL 2019;13:614-626. WELSH JB, DERDZINSKI M, PARKER AS, PUHR S, JIMENEZ A, WALKER T. REAL-TIME SHARING AND FOLLOWING OF CONTINUOUS GLUCOSE MONITORING DATA IN YOUTH. DIABETES THER 2019;10:751-755. PUHR S, DERDZINSKI M, WELSH JB, PARKER AS, WALKER T, PRICE DA. REAL-WORLD HYPOGLYCEMIA AVOIDANCE WITH A CONTINUOUS GLUCOSE MONITORING SYSTEM'S PREDICTIVE LOW GLUCOSE ALERT. DIABETES TECHNOL THER 2019;21:155-158".
2022/03/24 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 20 MMOL/L (360 MG/DL). THE POD WAS WORN BETWEEN 36 AND 48 HOURS. IT WAS NOTED THAT THE CANNULA WAS BENT. NO INFORMATION WAS PROVIDED ON HOW THE HYPERGLYCEMIA WAS TREATED. DEVICE WAS DISCARDED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/03/24 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 20 MMOL/L (360 MG/DL). THE POD WAS WORN BETWEEN 36 AND 48 HOURS. IT WAS NOTED THAT THE CANNULA WAS BENT. NO INFORMATION WAS PROVIDED ON HOW THE HYPERGLYCEMIA WAS TREATED. DEVICE WAS DISCARDED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/03/24 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 20 MMOL/L (360 MG/DL). THE POD WAS WORN BETWEEN 36 AND 48 HOURS. IT WAS NOTED THAT THE CANNULA WAS BENT. NO INFORMATION WAS PROVIDED ON HOW THE HYPERGLYCEMIA WAS TREATED. DEVICE WAS DISCARDED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/03/22 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMFailure to Fire No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED BY THE PATIENT THAT THE CANNULA DID NOT DEPLOY OR INSERT AS INTENDED DURING ACTIVATION. THE PINK SLIDE WAS NOT FORWARD, INDICATING A NEEDLE MECHANISM FAILURE. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/24 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 250 MG/DL BEFORE REPLACING THE POD. THE POD WAS WORN BETWEEN 4 AND 24 HOURS ON THE ABDOMEN. IT WAS NOTED THAT THE CANNULA WAS BENT. HYPERGLYCEMIA TREATED WITH A NEW POD. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/23 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMPremature Activation No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED BY THE PATIENT THAT THEY HAD A POD WHERE THE NEEDLE DEPLOYED EARLY BEFORE THE POD WAS APPLIED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/25 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 16.7 MMOL/L (300.6 MG/DL). THE POD WAS WORN BETWEEN 4 AND 24 HOURS ON THE ARM. IT WAS NOTED THAT THE CANNULA WAS BENT AND FLUID LEAKING. HYPERGLYCEMIA TREATED WITH A NEW POD AND PEN CORRECTION. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/23 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMPremature Activation No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED BY THE PATIENT THAT THEY HAD A POD WHERE THE NEEDLE DEPLOYED EARLY BEFORE THE POD WAS APPLIED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/22 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH, PODS 10-PACKMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE (BG) LEVELS REACHED 19.3 MMOL/L (347.4 MG/DL) WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS ON THE LEG. INSULIN WAS LEAKING OUT OF THE POD. THE POD WAS REMOVED, AND THE CANNULA WAS NOTED TO BE BENT. A NEW POD WAS APPLIED TO TREAT THE HYPERGLYCEMIA. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/16 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH, PODS 10-PACKPremature Activation No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT THE CANNULA DEPLOYED EARLY, INDICATING A FAILURE OF THE NEEDLE MECHANISM. THE PATIENT'S BLOOD GLUCOSE LEVELS WERE UNAFFECTED, AND THE POD WAS NOT WORN. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/19 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH, PODS 10-PACKPremature Activation No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT THE CANNULA DEPLOYED EARLY, INDICATING A FAILURE OF THE NEEDLE MECHANISM. THE PATIENT'S BLOOD GLUCOSE LEVELS WERE UNAFFECTED, AND THE POD WAS NOT WORN. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/23 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN PUMPPremature Activation No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT THE CANNULA DEPLOYED EARLY, INDICATING A FAILURE OF THE NEEDLE MECHANISM. THE PATIENT'S BLOOD GLUCOSE LEVELS WERE UNAFFECTED, AND THE POD WAS NOT WORN. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/23 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THAT A PATIENT'S BLOOD GLUCOSE LEVELS (BG) REACHED OVER 500 MG/DL WHILE WEARING THE POD BETWEEN 1 AND 4 HOURS. THE PATIENT REPORTED CANNULA BEING DISLODGED, WHILE WEARING IT ON THE HIPS/BUTTOCKS. FOR TREATMENT, THE PATIENT CHANGED OUT THE POD FOR A NEW POD. THE POD WAS DISCARDED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/06 5:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THAT A PATIENT'S BLOOD GLUCOSE LEVELS (BG) REACHED OVER 500 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. THE PATIENT REPORTED CANNULA BEING DISLODGED, WHILE WEARING IT ON THE LEG. FOR TREATMENT, THE PATIENT CHANGED OUT THE POD FOR A NEW POD. THE POD WAS DISCARDED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/07 5:00:00InjuryINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMInsufficient InformationPurulent Discharge; Skin InfectionEvent Description: IT WAS REPORTED THAT AFTER WEARING THE POD ON THE ARM LONGER THAN 48 HOURS, THE SITE WAS RED, INFECTED WITH SOME DISCHARGE. THE PATIENT VISITED THE DOCTOR, WHERE WAS PRESCRIBED ANTIBIOTICS (AMOXICILLIN) AND A CREAM (FUCIDIN) TO BE USED 3 TIMES A DAY UNTIL IT CLEARS. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO CUSTOMER'S INFUSION SITE INFECTION. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. THE OMNIPOD IS ISO10993 COMPLIANT, UNDERGOING CYTOTOXICITY, SENSITIZATION, GENOTOXICITY, HEMOLYSIS, IRRITATION OR INTRACUTANEOUSLY REACTIVITY, SYSTEMIC TOXICITY, AND IMPLANTATION EFFECTS TESTING. THE OMNIPOD IS STERILIZED WITH 100% ETHYLENE OXIDE GAS WITH A STERILITY ASSURANCE LEVEL OF 10-6  PER ISO11135  AND EO RESIDUAL LEVELS IN COMPLIANCE WITH ISO10993. EACH LOT  IS CONFIRMED TO MEET REQUIREMENTS FOR NON-PYROGENICITY PER ISO10993 AND STERILITY PER ISO11135 PRIOR TO RELEASE.
2022/03/15 4:00:00InjuryINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMInsufficient InformationHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE (BG) LEVELS EXCEEDING 250 MG/DL, WHILE WEARING THE POD. NO INFORMATION WAS PROVIDED ON THE TYPE OF TREATMENT GIVEN AT THE HOSPITAL. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED HOSPITALIZATION AND HYPERGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/03/18 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMDifficult to InsertHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 27 MMOL/L (486 MG/DL) WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. THE PATIENT REPORTED BEING UNSURE IF THE CANNULA WAS PROPERLY SEATED IN THE INFUSION SITE. AS TREATMENT, A NEW POD WAS PLACED. THE POD HAS BEEN DISCARDED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE AVAILABLE FOR INVESTIGATION BECAUSE IT WAS DISCARDED BY THE PATIENT. IT WAS REPORTED THE CANNULA WAS POSSIBLY NOT INSERTED CORRECTLY INTO THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/03/18 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMDifficult to InsertHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 27 MMOL/L (486 MG/DL) WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. THE PATIENT REPORTED BEING UNSURE IF THE CANNULA WAS PROPERLY SEATED IN THE INFUSION SITE. AS TREATMENT, A NEW POD WAS PLACED. THE POD HAS BEEN DISCARDED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE AVAILABLE FOR INVESTIGATION BECAUSE IT WAS DISCARDED BY THE PATIENT. IT WAS REPORTED THE CANNULA WAS POSSIBLY NOT INSERTED CORRECTLY INTO THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/03/17 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM Activation, Positioning or SeparationProblem No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED A PATIENT HAD A POD IN WHICH THE PINK SLIDE DID NOT MOVE FORWARD WHEN THE POD WAS ACTIVATED; THIS INDICATES A NEEDLE MECHANISM FAILURE OCCURRED. AS TREATMENT, THE PATIENT APPLIED A NEW POD. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/24 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED OVER 300 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. WHEN REMOVED FROM THE INFUSION SITE (ARM), THE POD'S CANNULA WAS FOUND BENT. AS TREATMENT, A MANUAL INJECTION OF INSULIN WAS DELIVERED AND A NEW POD WAS APPLIED. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/17 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMRetraction ProblemPain; Swelling/ EdemaEvent Description: IT WAS REPORTED THAT THE NEEDLE DID NOT RETRACT WHEN THE POD WAS ACTIVATED; THIS INDICATES A NEEDLE MECHANISM FAILURE OCCURRED. THE POD WAS WORN LONGER THAN 48 HOURS AND PATIENT EXPERIENCED PAIN AND SWELLING DUE TO THE REPORTED ISSUE. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/24 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMPremature Activation No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT THE NEEDLE DEPLOYED EARLY WHEN THE POD WAS ACTIVATED; THIS INDICATES A NEEDLE MECHANISM FAILURE OCCURRED. THE POD WAS NOT WORN. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/22 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMDifficult to InsertHyperglycemiaEvent Description: IT WAS REPORTED THAT A PATIENT'S BLOOD GLUCOSE LEVELS (BG) REACHED 380 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. THE PATIENT REPORTED BEING UNSURE IF THE CANNULA WAS PROPERLY SEATED WHILE WEARING IT ON UNKNOWN LOCATION. FOR TREATMENT, THE PATIENT CHANGED OUT THE POD FOR A NEW POD. THE POD WAS DISCARDED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THE CANNULA WAS POSSIBLY NOT INSERTED CORRECTLY INTO THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/24 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT A PATIENT'S BLOOD GLUCOSE LEVELS (BG) REACHED OVER 500 MG/DL WHILE WEARING THE POD BETWEEN 36 AND 48 HOURS. THE PATIENT REPORTED CANNULA BEING BENT WHILE WEARING IT ON THE ARM. FOR TREATMENT, THE PATIENT CHANGED OUT THE POD AND GAVE CORRECTION BOLUS. THE POD WAS DISCARDED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/22 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMPremature Activation No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT THE NEEDLE MECHANISM HAD FULLY DEPLOYED BEFORE THE POD WAS ABLE TO BE USED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/01/28 5:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMInsufficient InformationHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE (BG) LEVELS REACHED 430 MG/DL, WHILE WEARING THE POD ON THE ABDOMEN LONGER THAN 48 HOURS. A NEW POD WAS APPLIED TO TREAT THE HYPERGLYCEMIA. Manufacturer Narrative: INVESTIGATION DISCOVERED A TEAR ON THE EXPOSED PORTION OF THE SOFT CANNULA. DURING INVESTIGATION, LEAKING WAS OBSERVED FROM THE EXTERNAL TEAR, WHICH DIVERTED THE FLUID FROM COMPLETING THE FLUID PATH. IT COULD NOT BE DETERMINED WHEN THE TEAR OCCURRED OR IF IT CONTRIBUTED TO THE REPORTED EVENT. THE DOWNLOADED DATA DID NOT SHOW ANY TIMEOUTS OR DRIVE STALLS THAT COULD INDICATE A FAILURE OF THE DEVICE TO DELIVER INSULIN. ALTHOUGH DAMAGE WAS OBSERVED ON THE EXPOSED PORTION OF THE SOFT CANNULA, THE TIMING AND CAUSE COULD NOT BE DETERMINED. NO OTHER DAMAGES OR ABNORMALITIES WERE FOUND THAT COULD AFFECT INSULIN DELIVERY. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/01/07 5:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMInsufficient InformationHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE (BG) LEVELS REACHED 360 MG/DL, WHILE WEARING THE POD ON THE LEG LONGER THAN 48 HOURS. A MANUAL INSULIN INJECTION WAS ADMINISTERED TO TREAT THE HYPERGLYCEMIA. Manufacturer Narrative: THE SOFT CANNULA WAS OBSERVED TO BE FLATTENED AND STRETCHED, MEASURING OUT OF SPECIFICATION AT 1.109 INCHES. IT IS UNKNOWN HOW OR WHEN THIS DAMAGE OCCURRED. NO TIMEOUTS OR DRIVE STALLS WERE SEEN IN THE DEVICE DATA THAT WOULD INDICATE A FAILURE TO DELIVER INSULIN. NO OTHER COMPONENTS WERE OBSERVED TO BE DAMAGED. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/18 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMFailure to Fire No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THE NEEDLE AND CANNULA DID NOT DEPLOY, INDICATING A FAILURE OF THE NEEDLE MECHANISM. THE PATIENT'S BLOOD GLUCOSE LEVELS WERE UNAFFECTED. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/18 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMFailure to Fire No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THE NEEDLE AND CANNULA DID NOT DEPLOY, INDICATING A FAILURE OF THE NEEDLE MECHANISM. THE PATIENT'S BLOOD GLUCOSE LEVELS WERE UNAFFECTED, AND THE POD WAS NOT WORN. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/02/24 5:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH, PODS 10-PACKPremature Activation No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THE NEEDLE DEPLOYED EARLY, INDICATING A FAILURE OF THE NEEDLE MECHANISM. THE PATIENT'S BLOOD GLUCOSE LEVELS WERE UNAFFECTED, AND THE POD WAS NOT WORN. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/20 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM Activation, Positioning or SeparationProblem No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THE PINK SLIDE DID NOT MOVE FORWARD, INDICATING A FAILURE OF THE NEEDLE MECHANISM. THE PATIENT'S BLOOD GLUCOSE LEVELS WERE UNAFFECTED. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/02/12 5:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE (BG) LEVELS REACHED 18 MMOL/L (324 MG/DL) WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS ON THE BACK. INSULIN WAS NOTICED TO BE LEAKING OUT. THE POD WAS REMOVED, AND THE CANNULA WAS FOUND TO BE BENT. A NEW POD WAS APPLIED TO TREAT THE HYPERGLYCEMIA. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/01/26 5:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE (BG) LEVELS REACHED 18 MMOL/L (324 MG/DL) WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS ON THE BACK. INSULIN WAS NOTICED TO BE LEAKING OUT. THE POD WAS REMOVED, AND THE CANNULA WAS FOUND TO BE BENT. A NEW POD WAS APPLIED TO TREAT THE HYPERGLYCEMIA. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/01/22 5:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE (BG) LEVELS REACHED 15 MMOL/L (270 MG/DL) WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS ON THE BACK. INSULIN WAS NOTICED TO BE LEAKING OUT. THE POD WAS REMOVED, AND THE CANNULA WAS FOUND TO BE BENT. A NEW POD WAS APPLIED TO TREAT THE HYPERGLYCEMIA. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/19 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE (BG) LEVELS REACHED 16.3 MMOL/L (293.4 MG/DL) WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS ON THE BACK. THE POD WAS REMOVED, AND THE CANNULA WAS NOTED TO BE BENT. HYPERGLYCEMIA TREATED BY PATIENT ACTIVATING NEW POD AND BOLUS. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/01/05 5:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMFailure to Fire No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THE NEEDLE DID NOT DEPLOY, INDICATING A FAILURE OF THE NEEDLE MECHANISM. THE PATIENT'S BLOOD GLUCOSE LEVELS WERE UNAFFECTED, AND THE POD WAS NOT WORN. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/01 5:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMFailure to Fire No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THE NEEDLE DID NOT DEPLOY, INDICATING A FAILURE OF THE NEEDLE MECHANISM. THE PATIENT'S BLOOD GLUCOSE LEVELS WERE UNAFFECTED, AND THE POD WAS NOT WORN. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/21 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMFailure to Fire No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THE NEEDLE DID NOT DEPLOY, INDICATING A FAILURE OF THE NEEDLE MECHANISM. THE PATIENT'S BLOOD GLUCOSE LEVELS WERE UNAFFECTED, AND THE POD WAS NOT WORN. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/03/19 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMFailure to Fire No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THE NEEDLE DID NOT DEPLOY, INDICATING A FAILURE OF THE NEEDLE MECHANISM. THE PATIENT'S BLOOD GLUCOSE LEVELS WERE UNAFFECTED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/22 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN PUMPPremature ActivationHyperglycemiaEvent Description: IT WAS REPORTED THE CANNULA DEPLOYED EARLY, INDICATING A FAILURE OF THE NEEDLE MECHANISM. THE PATIENT'S BLOOD GLUCOSE LEVELS ROSE UP TO 22 MMOL/L (396 MG/DL). Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/17 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMPremature ActivationHyperglycemiaEvent Description: IT WAS REPORTED THE CANNULA DEPLOYED EARLY, INDICATING A FAILURE OF THE NEEDLE MECHANISM. THE PATIENT'S BLOOD GLUCOSE LEVELS ROSE UP TO 21 MMOL/L (378 MG/DL). Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/04 5:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH, PODS 10-PACKPremature Activation No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THE NEEDLE DEPLOYED EARLY, INDICATING A FAILURE OF THE NEEDLE MECHANISM. THE PATIENT'S BLOOD GLUCOSE LEVELS WERE UNAFFECTED, AND THE POD WAS NOT WORN. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/02/12 5:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE (BG) LEVELS REACHED 23 MMOL/L (414 MG/DL) WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS ON THE BACK. INSULIN WAS NOTICED TO BE LEAKING OUT. THE POD WAS REMOVED, AND THE CANNULA WAS FOUND TO BE BENT. A NEW POD WAS APPLIED TO TREAT THE HYPERGLYCEMIA. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/20 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE (BG) LEVELS REACHED 310 MG/DL, WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS ON THE ABDOMEN. MULTIPLE CORRECTIONS WERE ADMINISTERED USING THE POD, BUT THE BG LEVELS DID NOT DECREASE. THE POD WAS REMOVED, AND THE CANNULA WAS NOTED TO BE BENT. A NEW POD WAS APPLIED TO TREAT THE HYPERGLYCEMIA. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/23 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMDifficult to Insert; Material Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 40 MMOL/L (720 MG/DL) WHILE WEARING THE POD BETWEEN 1 AND 4 HOURS. THE PATIENT REPORTED THE CANNULA WAS BENT AND NOT PROPERLY INSERTED IN THE INFUSION SITE. AS TREATMENT, AN 8 UNIT CORRECTION WAS DELIVERED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THE CANNULA WAS BENT AND POSSIBLY NOT INSERTED CORRECTLY INTO THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/14 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMDifficult to InsertHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 21 MMOL/L (378 MG/DL) WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. THE PATIENT REPORTED BEING UNSURE IF THE CANNULA WAS PROPERLY INSERTED IN THE INFUSION SITE. AS TREATMENT, A NEW POD WAS APPLIED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THE CANNULA WAS POSSIBLY NOT INSERTED CORRECTLY INTO THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/03/19 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMFailure to Fire No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THE NEEDLE DID NOT DEPLOY AND THE CANNULA WAS NOT VISIBLE. THE POD WAS WORN FOR LESS THAN AN HOUR. NO ADVERSE PATIENT IMPACT WAS REPORTED. Manufacturer Narrative: WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/22 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMFailure to Fire No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THE PINK SLIDE DID NOT MOVE FORWARD AND THE CANNULA WAS NOT VISIBLE; INDICATING THE NEEDLE MECHANISM DID NOT FUNCTION AS INTENDED. THE POD WAS NOT WORN AND NO ADVERSE PATIENT IMPACT WAS REPORTED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/23 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMFailure to Fire No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THE PINK SLIDE DID NOT MOVE FORWARD AND THE CANNULA WAS NOT VISIBLE; INDICATING THE NEEDLE MECHANISM DID NOT FUNCTION AS INTENDED. THE POD WAS NOT WORN AND NO ADVERSE PATIENT IMPACT WAS REPORTED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/23 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMFailure to Fire No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THE PINK SLIDE DID NOT MOVE FORWARD AND THE CANNULA WAS NOT VISIBLE; INDICATING THE NEEDLE MECHANISM DID NOT FUNCTION AS INTENDED. THE POD WAS NOT WORN AND NO ADVERSE PATIENT IMPACT WAS REPORTED. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/ RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/18 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMDifficult to InsertHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 27 MMOL/L (486 MG/DL) WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. THE PATIENT REPORTED BEING UNSURE IF THE CANNULA WAS PROPERLY SEATED IN THE INFUSION SITE. AS TREATMENT, A NEW POD WAS PLACED. THE POD HAS BEEN DISCARDED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE AVAILABLE FOR INVESTIGATION BECAUSE IT WAS DISCARDED BY THE PATIENT. IT WAS REPORTED THE CANNULA WAS POSSIBLY NOT INSERTED CORRECTLY INTO THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/03/18 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMDifficult to InsertHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 27 MMOL/L (486 MG/DL) WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. THE PATIENT REPORTED BEING UNSURE IF THE CANNULA WAS PROPERLY SEATED IN THE INFUSION SITE. AS TREATMENT, A NEW POD WAS PLACED. THE POD HAS BEEN DISCARDED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE AVAILABLE FOR INVESTIGATION BECAUSE IT WAS DISCARDED BY THE PATIENT. IT WAS REPORTED THE CANNULA WAS POSSIBLY NOT INSERTED CORRECTLY INTO THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/18 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMDifficult to InsertHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 27 MMOL/L (486 MG/DL) WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. THE PATIENT REPORTED BEING UNSURE IF THE CANNULA WAS PROPERLY SEATED IN THE INFUSION SITE. AS TREATMENT, A NEW POD WAS PLACED. THE POD HAS BEEN DISCARDED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE AVAILABLE FOR INVESTIGATION BECAUSE IT WAS DISCARDED BY THE PATIENT. IT WAS REPORTED THE CANNULA WAS POSSIBLY NOT INSERTED CORRECTLY INTO THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/03/18 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMDifficult to InsertHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 27 MMOL/L (486 MG/DL) WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. THE PATIENT REPORTED BEING UNSURE IF THE CANNULA WAS PROPERLY SEATED IN THE INFUSION SITE. AS TREATMENT, A NEW POD WAS PLACED. THE POD HAS BEEN DISCARDED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE AVAILABLE FOR INVESTIGATION BECAUSE IT WAS DISCARDED BY THE PATIENT. IT WAS REPORTED THE CANNULA WAS POSSIBLY NOT INSERTED CORRECTLY INTO THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/03/18 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMDifficult to InsertHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 27 MMOL/L (486 MG/DL) WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. THE PATIENT REPORTED BEING UNSURE IF THE CANNULA WAS PROPERLY SEATED IN THE INFUSION SITE. AS TREATMENT, A NEW POD WAS PLACED. THE POD HAS BEEN DISCARDED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE AVAILABLE FOR INVESTIGATION BECAUSE IT WAS DISCARDED BY THE PATIENT. IT WAS REPORTED THE CANNULA WAS POSSIBLY NOT INSERTED CORRECTLY INTO THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/03/24 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMPremature Activation No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THE NEEDLE FULLY DEPLOYED BEFORE THE POD WAS ABLE TO BE USED; INDICATING THE NEEDLE MECHANISM DID NOT FUNCTION AS INTENDED. THE POD WAS NOT WORN AND NO ADVERSE PATIENT IMPACT WAS REPORTED. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/18 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMDifficult to InsertHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 27 MMOL/L (486 MG/DL) WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. THE PATIENT REPORTED BEING UNSURE IF THE CANNULA WAS PROPERLY SEATED IN THE INFUSION SITE. AS TREATMENT, A NEW POD WAS PLACED. THE POD HAS BEEN DISCARDED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE AVAILABLE FOR INVESTIGATION BECAUSE IT WAS DISCARDED BY THE PATIENT. IT WAS REPORTED THE CANNULA WAS POSSIBLY NOT INSERTED CORRECTLY INTO THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2021/07/29 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMFailure to FireHyperglycemiaEvent Description: IT WAS REPORTED THAT THE CANNULA DID NOT DEPLOY WHEN THE POD WAS ACTIVATED; THIS INDICATES A NEEDLE MECHANISM FAILURE OCCURRED. THE POD WAS WORN BETWEEN 1 AND 4 HOURS AND PATIENT REPORTED A BLOOD GLUCOSE LEVEL OF 280 MG/DL. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/18 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMDifficult to InsertHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 27 MMOL/L (486 MG/DL) WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. THE PATIENT REPORTED BEING UNSURE IF THE CANNULA WAS PROPERLY SEATED IN THE INFUSION SITE. AS TREATMENT, A NEW POD WAS PLACED. THE POD HAS BEEN DISCARDED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE AVAILABLE FOR INVESTIGATION BECAUSE IT WAS DISCARDED BY THE PATIENT. IT WAS REPORTED THE CANNULA WAS POSSIBLY NOT INSERTED CORRECTLY INTO THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/03/18 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMDifficult to InsertHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 27 MMOL/L (486 MG/DL) WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. THE PATIENT REPORTED BEING UNSURE IF THE CANNULA WAS PROPERLY SEATED IN THE INFUSION SITE. AS TREATMENT, A NEW POD WAS PLACED. THE POD HAS BEEN DISCARDED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE AVAILABLE FOR INVESTIGATION BECAUSE IT WAS DISCARDED BY THE PATIENT. IT WAS REPORTED THE CANNULA WAS POSSIBLY NOT INSERTED CORRECTLY INTO THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/03/18 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMDifficult to InsertHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 27 MMOL/L (486 MG/DL) WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. THE PATIENT REPORTED BEING UNSURE IF THE CANNULA WAS PROPERLY SEATED IN THE INFUSION SITE. AS TREATMENT, A NEW POD WAS PLACED. THE POD HAS BEEN DISCARDED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE AVAILABLE FOR INVESTIGATION BECAUSE IT WAS DISCARDED BY THE PATIENT. IT WAS REPORTED THE CANNULA WAS POSSIBLY NOT INSERTED CORRECTLY INTO THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/03/25 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMPremature Activation No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THE NEEDLE FULLY DEPLOYED BEFORE THE POD WAS ABLE TO BE USED; INDICATING THE NEEDLE MECHANISM DID NOT FUNCTION AS INTENDED. THE POD WAS NOT WORN AND NO ADVERSE PATIENT IMPACT WAS REPORTED. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/08 5:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemia; Skin Inflammation/ IrritationEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS EXCEEDED 400 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. WHEN REMOVED FROM THE INFUSION SITE (HIP/BUTTOCKS), THE POD'S CANNULA WAS FOUND BENT. THE SITE WAS SLIGHTLY IRRITATED. AS TREATMENT FOR HYPERGLYCEMIA, A CORRECTION OF INSULIN WAS DELIVERED. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/01/17 5:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMInsufficient InformationHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE ROSE TO 27 MMOL/L (486 MG/DL). AN OCCLUSION ALARM OCCURRED WHILE WORN ON THE PATIENT'S ABDOMEN FOR BETWEEN 36 AND 48 HOURS. Manufacturer Narrative: THE DOWNLOAD DATA SHOWS TIMEOUTS BEFORE GENERATING AN 0X14 ALARM DURING OPERATION, INDICATING AN OCCLUSION ALONG THE FLUID PATH. THE DEVICE WAS RUN WITH A DIFFERENT PDM. THE FIRST RERUN DOWNLOAD DATA SHOWS THE DEVICE WAS ABLE TO DELIVER A 5 UNIT BOLUS WITHOUT GENERATING AN OCCLUSION ALARM, HOWEVER TIMEOUTS WERE STILL PRESENT IN THE DATA. DURING THE RERUN OF THE DEVICE, IT WAS ORIGINALLY OBSERVED THAT NO FLUID WAS COMING OUT OF THE DISTAL TIP DESPITE THE PRESENCE OF FLUID IN THE RESERVOIR. DURING DELIVERY, DEBRIS CAME OUT OF THE SOFT CANNULA, FOLLOWED BY AN EXCESS OF FLUID, INDICATING THE OCCLUSION HAD CLEARED ITSELF DURING THE RERUN. INVESTIGATION OF THE DEVICE AFTER THE RERUN FOUND THAT FLUID WAS ABLE TO FLOW THROUGH THE COMPLETE FLUID PATH AND NO OCCLUSIONS WERE OBSERVED WITHIN THE SOFT CANNULA OR THE FORMED NEEDLE. NO OTHER DAMAGES OR DEFICIENCIES WERE OBSERVED THAT WOULD PREVENT THE FLOW OF INSULIN. SINCE FLUID FLOWED NORMALLY, AND NO OCCLUSIONS WERE OBSERVED, THE DEVICE WAS RERUN A SECOND TIME TO SEE IF IT WOULD REPLICATE THE TIMEOUTS. THE SECOND RERUN DOWNLOAD DATA SHOWS NO ALARM GENERATED BUT CONTINUED TO SHOW THE TIMEOUTS THROUGHOUT THE RERUN, DESPITE FLUID FLOWING OUT OF THE DEVICE DURING THE RERUN. INVESTIGATION OF THE LEAD SCREW AND TUBE NUT FOUND NO DAMAGES OR DEFICIENCIES THAT WOULD CAUSE THIS AMOUNT OF TIMEOUTS. THE EXACT CAUSE OF THESE TIMEOUTS COULD NOT BE DETERMINED. THE SECOND RERUN DOWNLOAD DATA SHOWED A ROTATIONAL SENSOR MALFUNCTION. INVESTIGATION OF THE RATCHET GEAR FOUND EXCESS PLASTIC ON ONE OF THE GEAR TEETH. IN ADDITION TO THAT, CONTAMINATION WAS FOUND ON THE COMMUTATOR CAP, CAUSING THE ROTATIONAL SENSOR MALFUNCTION. WHEN THIS OCCURRED COULD NOT BE DETERMINED. THE EXACT CAUSE OF THE DAMAGE AND CONTAMINATION COULD NOT BE DETERMINED. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/16 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Material Twisted/Bent; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 300 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. WHEN REMOVED FROM THE INFUSION SITE (UNKNOWN), THE POD'S CANNULA WAS FOUND DISLODGED. IT WAS ALSO STATED THAT THE DAUGHTERS CANNULA WAS FOUND BENT. AS TREATMENT, THE PATIENT REMOVED THE POD. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. WE ARE ALSO UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE AND FREEDOM FROM HAZARD ALARMS.
2022/02/20 5:00:00InjuryINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMInsufficient InformationHypersensitivity/Allergic reaction; Itching Sensation; Skin Inflammation/ IrritationEvent Description: IT WAS REPORTED THAT A SKIN IRRITATION CAUSING ITCHING AND A POTENTIAL ALLERGIC REACTION HAD OCCURRED WHILE WEARING THE POD LONGER THAN 48 HOURS. PATIENT SOUGH MEDICAL ATTENTION VIRTUALLY AND WAS PRESCRIBED BENADRYL, TO BE TAKEN ORALLY AS NEEDED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE SKIN IRRITATION. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/03/17 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM Activation, Positioning or SeparationProblem No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED A PATIENT HAD A POD IN WHICH THE PINK SLIDE DID NOT MOVE FORWARD WHEN THE POD WAS ACTIVATED; THIS INDICATES A NEEDLE MECHANISM FAILURE OCCURRED. AS TREATMENT, THE PATIENT APPLIED A NEW POD. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/01/15 5:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM Activation, Positioning or SeparationProblem No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED A PATIENT HAD A POD IN WHICH THE PINK SLIDE DID NOT MOVE FORWARD WHEN THE POD WAS ACTIVATED; THIS INDICATES A NEEDLE MECHANISM FAILURE OCCURRED. AS TREATMENT, THE PATIENT APPLIED A NEW POD. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/17 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM Activation, Positioning or SeparationProblem No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED A PATIENT HAD A POD IN WHICH THE PINK SLIDE DID NOT MOVE FORWARD WHEN THE POD WAS ACTIVATED; THIS INDICATES A NEEDLE MECHANISM FAILURE OCCURRED. AS TREATMENT, THE PATIENT APPLIED A NEW POD. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/17 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM Activation, Positioning or SeparationProblem No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED A PATIENT HAD A POD IN WHICH THE PINK SLIDE DID NOT MOVE FORWARD WHEN THE POD WAS ACTIVATED; THIS INDICATES A NEEDLE MECHANISM FAILURE OCCURRED. AS TREATMENT, THE PATIENT APPLIED A NEW POD. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/17 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM Activation, Positioning or SeparationProblem No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED A PATIENT HAD A POD IN WHICH THE PINK SLIDE DID NOT MOVE FORWARD WHEN THE POD WAS ACTIVATED; THIS INDICATES A NEEDLE MECHANISM FAILURE OCCURRED. AS TREATMENT, THE PATIENT APPLIED A NEW POD. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/17 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM Activation, Positioning or SeparationProblem No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED A PATIENT HAD A POD IN WHICH THE PINK SLIDE DID NOT MOVE FORWARD WHEN THE POD WAS ACTIVATED; THIS INDICATES A NEEDLE MECHANISM FAILURE OCCURRED. AS TREATMENT, THE PATIENT APPLIED A NEW POD. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/17 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM Activation, Positioning or SeparationProblem No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED A PATIENT HAD A POD IN WHICH THE PINK SLIDE DID NOT MOVE FORWARD WHEN THE POD WAS ACTIVATED; THIS INDICATES A NEEDLE MECHANISM FAILURE OCCURRED. AS TREATMENT, THE PATIENT APPLIED A NEW POD. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/19 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED OVER 300 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. WHEN REMOVED FROM THE INFUSION SITE (ABDOMEN), THE POD'S CANNULA WAS FOUND KINKED/BENT. AS TREATMENT FOR HYPERGLYCEMIA, A CORRECTION SHOT WAS DELIVERED AND A NEW POD WAS APPLIED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/17 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM Activation, Positioning or SeparationProblem No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED A PATIENT HAD A POD IN WHICH THE PINK SLIDE DID NOT MOVE FORWARD WHEN THE POD WAS ACTIVATED; THIS INDICATES A NEEDLE MECHANISM FAILURE OCCURRED. AS TREATMENT, THE PATIENT APPLIED A NEW POD. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/22 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED OVER 400 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. WHEN REMOVED FROM THE INFUSION SITE (ABDOMEN), THE POD'S CANNULA WAS FOUND BENT. MODERATE KETONES WERE ALSO PRESENT. AS TREATMENT, A MANUAL INJECTION OF INSULIN WAS DELIVERED AND A NEW POD WAS APPLIED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/21 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED ABOUT 270 MG/DL WHILE WEARING THE POD LONGER THAN 48 HOURS. WHEN REMOVED FROM THE INFUSION SITE (BACK), THE POD'S CANNULA WAS FOUND BENT. AS TREATMENT, A MANUAL INJECTION OF INSULIN WAS DELIVERED AND A NEW POD WAS APPLIED. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/22 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMDifficult to InsertHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE (BG) LEVELS REACHED OVER 400 MG/DL WHILE WEARING THE POD FOR ONE HOUR. DUE TO ELEVATED BG LEVELS, PATIENT WAS UNSURE IF CANNULA HAD PROPERLY INSERTED IN THE INFUSION SITE (LEG). KETONES WERE TESTED AND THE RESULTS WERE NEGATIVE. AS TREATMENT, A NEW POD WAS APPLIED. THIS POD WAS DISCARDED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THE CANNULA WAS POSSIBLY NOT INSERTED CORRECTLY INTO THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/23 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 394 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. WHEN REMOVED FROM THE INFUSION SITE (LEG), THE POD'S CANNULA WAS FOUND BENT. SMALL KETONES WERE ALSO PRESENT. AS TREATMENT, A NEW POD WAS APPLIED AND INSULIN WAS DELIVERED. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/20 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMFailure to FireHyperglycemiaEvent Description: IT WAS REPORTED BY THE PATIENT THAT THE CANNULA DID NOT DEPLOY OR INSERT AS INTENDED DURING ACTIVATION. THE PINK SLIDE WAS NOT FORWARD, INDICATING A NEEDLE MECHANISM FAILURE. BLOOD GLUCOSE LEVELS REACHED 269 MG/DL. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/23 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMPremature Activation No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT THE NEEDLE DEPLOYED EARLY WHEN THE POD WAS ACTIVATED; THIS INDICATES A NEEDLE MECHANISM FAILURE OCCURRED. THE POD WAS NOT WORN. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/07 5:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMUnintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT¿S BLOOD GLUCOSE LEVEL WAS "HIGH" (>27.8 MMOL/L,>500 MG/DL) WITH KETONES OF 0.5. THE POD WAS WORN BETWEEN 24 AND 36 HOURS ON THE LEG. IT WAS NOTED THAT THE ADHESIVE WAS NOT STICKING WELL AND THE CANNULA DISLODGED FROM THE SITE. HYPERGLYCEMIA TREATED WITH CORRECTIONAL BOLUS AND PEN CORRECTION. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/03/20 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN PUMPFailure to Fire No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED BY THE PATIENT THAT THE CANNULA DID NOT DEPLOY OR INSERT AS INTENDED DURING ACTIVATION. THE PINK SLIDE WAS NOT FORWARD, INDICATING A NEEDLE MECHANISM FAILURE. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/22 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMDifficult to InsertHyperglycemiaEvent Description: IT WAS REPORTED THAT A PATIENT'S BLOOD GLUCOSE LEVELS (BG) REACHED 375 MG/DL WHILE WEARING THE POD BETWEEN 1 AND 4 HOURS. THE PATIENT REPORTED BEING UNSURE IF THE CANNULA WAS PROPERLY SEATED WHILE WEARING IT ON UNKNOWN LOCATION. FOR TREATMENT, THE PATIENT CHANGED OUT THE POD FOR A NEW POD. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. IT WAS REPORTED THE CANNULA WAS POSSIBLY NOT INSERTED CORRECTLY INTO THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/04 5:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMMaterial Twisted/Bent; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THAT A PATIENT'S BLOOD GLUCOSE LEVELS (BG) REACHED 300 MG/DL. THE PATIENT REPORTED CANNULA BEING DISLODGED AND BENT, WHILE WEARING IT ON THE ABDOMEN. FOR TREATMENT, THE PATIENT CHANGED OUT THE POD FOR A NEW POD. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED AND BENT FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/22 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMFluid Leak; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THAT A PATIENT'S BLOOD GLUCOSE LEVELS (BG) REACHED 400 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. THE PATIENT REPORTED CANNULA BEING DISLODGED, WHILE WEARING IT ON THE ABDOMEN. FOR TREATMENT, THE PATIENT CHANGED OUT THE POD FOR A NEW POD. THE POD WAS LEAKING. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/02/01 5:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMPremature Activation No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT THE NEEDLE DEPLOYED EARLY WHEN THE POD WAS ACTIVATED; THIS INDICATES A NEEDLE MECHANISM FAILURE OCCURRED. THE POD WAS NOT WORN. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/02/01 5:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMPremature Activation No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT THE NEEDLE DEPLOYED EARLY WHEN THE POD WAS ACTIVATED; THIS INDICATES A NEEDLE MECHANISM FAILURE OCCURRED. THE POD WAS NOT WORN. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/03/24 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMFailure to Fire No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT THE PATIENT FOUND CANNULA HAD NOT DEPLOYED AS INTENDED. THE CANNULA WAS NOT VISIBLE, INDICATING A NEEDLE MECHANISM FAILURE. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/24 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMPremature Activation No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT THE NEEDLE MECHANISM HAD FULLY DEPLOYED BEFORE THE POD WAS ABLE TO BE USED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/24 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMPremature Activation No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT THE NEEDLE MECHANISM HAD FULLY DEPLOYED BEFORE THE POD WAS ABLE TO BE USED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/15 4:00:00InjuryINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMAdverse Event Without Identified Device or Use ProblemHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT WENT TO THE EMERGENCY ROOM (ER) AND WAS DIAGNOSED WITH BLOOD GLUCOSE (BG) VALUES THAT REACHED 473 MG/DL. THE KETONES WERE MODERATE. FOR TREATMENT, THE PATIENT WAS GIVEN SALINE AND A MANUAL INJECTION OF INSULIN. THE POD WAS WORN BETWEEN 24 AND 36 HOURS ON THE ARM. THE POD WAS DISCARDED AND THE PATIENT WAS DISCHARGED AFTER 3 HOURS. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED HOSPITALIZATION AND HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS. HIGH BLOOD GLUCOSE IS A COMMON SYMPTOM FOR PEOPLE WITH DIABETES (GLUCOSE MONITORING DATA FROM PEOPLE WITH DIABETES INDICATE THAT ON AVERAGE, THEY CAN EXPERIENCE BLOOD GLUCOSE LEVELS ABOVE 250 MG/DL FOR 14-25% OF THE TIME [1][2][3]), AND IT WOULD BE CHALLENGING TO SPECULATE ON A CAUSE FOR THE COMPLAINTS WITHOUT RECEIVING THE DEVICES BACK FOR AN ENGINEERING INVESTIGATION. BECK RW, BERGENSTAL RM, CHENG P, KOLLMAN C, CARLSON AL, JOHNSON ML, RODBARD D. THE RELATIONSHIPS BETWEEN TIME IN RANGE, HYPERGLYCEMIA METRICS, AND HBA1C. J DIABETES SCI TECHNOL 2019;13:614-626 WELSH JB, DERDZINSKI M, PARKER AS, PUHR S, JIMENEZ A, WALKER T. REAL-TIME SHARING AND FOLLOWING OF CONTINUOUS GLUCOSE MONITORING DATA IN YOUTH. DIABETES THER 2019;10:751-755. PUHR S, DERDZINSKI M, WELSH JB, PARKER AS, WALKER T, PRICE DA. REAL-WORLD HYPOGLYCEMIA AVOIDANCE WITH A CONTINUOUS GLUCOSE MONITORING SYSTEM'S PREDICTIVE LOW GLUCOSE ALERT. DIABETES TECHNOL THER 2019;21:155-158.
2022/02/07 5:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMInsufficient InformationHyperglycemiaEvent Description: IT WAS REPORTED THAT A PATIENT'S BLOOD GLUCOSE LEVELS (BG) REACHED OVER 250 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS ON THE LEG. FOR TREATMENT, THE PATIENT GAVE A CORRECTION BOLUS. Manufacturer Narrative: THE DOWNLOAD DATA SHOWS THAT THE DEVICE RAN FOR 583 PULSES WITHOUT GENERATING A HAZARD ALARM. NO TIMEOUTS OR DRIVE STALLS WERE OBSERVED THAT WOULD GENERATE AN ALARM. THE DEVICE WAS RERUN WITH A DIFFERENT PDM. THE RERUN DOWNLOAD DATA SHOWS THE DEVICE WAS ABLE TO FUNCTION NORMALLY AND DELIVER A 5 UNIT BOLUS WITHOUT GENERATING A HAZARD ALARM. NO OTHER DAMAGES OR DEFICIENCIES WERE OBSERVED THAT WOULD CONTRIBUTE TO THE REPORTED EVENT. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. THE SOFT CANNULA MEASURED OUT OF SPECIFICATION AT 1.319 INCHES. A TEAR WAS OBSERVED ON THE EXPOSED PORTION OF THE SOFT CANNULA, CAUSING FLUID TO LEAK. WHEN THIS DAMAGE OCCURRED COULD NOT BE DETERMINED. THE EXACT CAUSE OF THIS DAMAGE COULD NOT BE DETERMINED. IT COULD NOT CONCLUSIVELY BE DETERMINED IF THIS DAMAGE CONTRIBUTED TO THE REPORTED EVENT. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/18 4:00:00InjuryINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMAdverse Event Without Identified Device or Use ProblemAbscess; Skin InfectionEvent Description: IT WAS REPORTED THAT THE PATIENT WENT TO A DOCTOR AND WAS DIAGNOSED WITH A SKIN INFECTION CALLED A ABSCESS. THE PATIENT'S BLOOD GLUCOSE (BG) VALUES REACHED 250 MG/DL. FOR TREATMENT, THE PATIENT WAS PRESCRIBED A OINTMENT CALLED MUPIROCIN AND GIVEN ADVICE. THE POD WAS WORN LONGER THAN 48 HOURS ON THE LEG. THE POD WAS DISCARDED AND PATIENT WAS DISCHARGED ON THE SAME DAY. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO CUSTOMER'S INFUSION SITE INFECTION. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. THE OMNIPOD IS ISO10993 COMPLIANT, UNDERGOING CYTOTOXICITY, SENSITIZATION, GENOTOXICITY, HEMOLYSIS, IRRITATION OR INTRACUTANEOUS REACTIVITY, SYSTEMIC TOXICITY, AND IMPLANTATION EFFECTS TESTING. THE OMNIPOD IS STERILIZED WITH 100% ETHYLENE OXIDE GAS WITH A STERILITY ASSURANCE LEVEL OF 10-6  PER ISO11135  AND EO RESIDUAL LEVELS IN COMPLIANCE WITH ISO10993. EACH LOT  IS CONFIRMED TO MEET REQUIREMENTS FOR NON-PYROGENICITY PER ISO10993 AND STERILITY PER ISO11135 PRIOR TO RELEASE.
2022/03/14 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMFailure to FireHyperglycemiaEvent Description: IT WAS REPORTED BY THE PATIENT THAT THE CANNULA DID NOT DEPLOY OR INSERT AS INTENDED DURING ACTIVATION. THE PINK SLIDE WAS NOT FORWARD, INDICATING A NEEDLE MECHANISM FAILURE. BLOOD GLUCOSE LEVELS REACHED OVER 250 MG/DL. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/01/27 5:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMInsufficient InformationHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 378 MG/DL WHILE WEARING THE POD BETWEEN 1 AND 4 HOURS ON THE ABDOMEN. AS TREATMENT, A MANUAL INJECTION OF INSULIN WAS DELIVERED AND A NEW POD WAS APPLIED. Manufacturer Narrative: THE DOWNLOAD DATA SHOWS THE DEVICE COMPLETED 228 PULSES BEFORE GENERATING AN 0X40 ALARM, INDICATING A SAFETY SENSOR TRIGGER FROM EXCEEDING THE MAXIMUM OPEN COUNT. THE ROTATIONAL SENSOR DATA SHOWS A ROTATIONAL SENSOR MALFUNCTION. INVESTIGATION OF THE COMMUTATOR CAP FOUND EVIDENCE OF CONTAMINATION AND DISCOLORATION CAUSED BY FLUID LEAKING ONTO THE COMMUTATOR CAP. A LEAK TEST WAS PERFORMED ON THE DEVICE. A LEAK WAS DISCOVERED ON THE RESERVOIR FROM DAMAGE AROUND THE FILL PORT. FLUID LEAKED FROM THE DAMAGE AND CONTAMINATED THE COMMUTATOR CAP, CAUSING THE ROTATIONAL SENSOR MALFUNCTION AND THE ALARM TO GENERATE, STOPPING THE DELIVERY OF INSULIN. AS THE LEAKING CONTINUED, CORROSION BEGAN TO FORM ON COMPONENTS INCLUDING THE BATTERIES, PCB BOARD, AND TOP/BOTTOM HOUSING. THIS CORROSION CAUSED THE BATTERIES TO MEASURE LOWER THAN EXPECTED. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/17 4:00:00InjuryINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMInsufficient InformationRash; Skin Inflammation/ IrritationEvent Description: IT WAS REPORTED BY THE PATIENT'S MOTHER THAT THE PATIENT HAD A SKIN IRRITATION CAUSING IRRITATION, BLISTERED RAISING UP, BLEEDING AND REDNESS HAD OCCURRED WHILE WEARING THE POD FOR MORE THAN 48 HOURS ON THE LEG. PATIENT VISITED PHYSICIAN AND WAS PRESCRIBED ANTIBIOTIC CORTISONE CREAM. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE SKIN IRRITATION. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. THE OMNIPOD IS ISO10993 COMPLIANT, UNDERGOING CYTOTOXICITY, SENSITIZATION, GENOTOXICITY, HEMOLYSIS, IRRITATION OR INTRACUTANEOUS REACTIVITY, SYSTEMIC TOXICITY, AND IMPLANTATION EFFECTS TESTING. THE OMNIPOD IS STERILIZED WITH 100% ETHYLENE OXIDE GAS WITH A STERILITY ASSURANCE LEVEL OF 10-6  PER ISO11135  AND EO RESIDUAL LEVELS IN COMPLIANCE WITH ISO10993. EACH LOT  IS CONFIRMED TO MEET REQUIREMENTS FOR NON-PYROGENICITY PER ISO10993 AND STERILITY PER ISO11135 PRIOR TO RELEASE.
2022/03/17 4:00:00InjuryINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMFailure to ChargeHyperglycemia; Vomiting; Diabetic KetoacidosisEvent Description: IT WAS REPORTED THAT THE PATIENT VISITED THE EMERGENCY ROOM (ER) DUE TO DIABETIC KETOACIDOSIS (DKA) HIGH BLOOD GLUCOSE 9BG) LEVELS OF 16 MMOL/L (288 MG/DL) AND VOMITING, WHILE ON THE OMNIPOD DEVICE AND NOT BEING ABLE TO USE IT AS THE PERSONAL DIABETES MANAGER (PDM) HAD STOPPED WORKING DUE TO A BROKEN CHARGING PORT. AT THE HOSPITAL, THE PATIENT WAS GIVEN FLUIDS, ANTI SICKNESS MEDICINE AND AN INTRAVENOUS (IV) DRIP OF PARACETAMOL AND INSULIN. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED ER VISIT AND DIABETIC KETOACIDOSIS. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/21 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH, PODS 10-PACKLoss of or Failure to Bond; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) READ HIGH (>500 MG/DL) WHILE WEARING THE POD. THE POD REPORTEDLY FELL OFF THE INFUSION SITE, CAUSING THE CANNULA TO DISLODGE. AS TREATMENT, A NEW POD WAS PLACED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/03/16 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMFluid Leak; Material Twisted/Bent; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 320 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. WHEN REMOVED FROM THE INFUSION SITE (ABDOMEN), THE POD'S CANNULA WAS FOUND TO BE DISLODGED AS WELL AS BENT. IN ADDITION THE POD WAS LEAKING DURING WEAR. AS TREATMENT, THE PATIENT APPLIED A NEW POD. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. IN ADDITION WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/21 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH, PODS 10-PACKLoss of or Failure to Bond; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) READ HIGH (>500 MG/DL) WHILE WEARING THE POD. THE POD REPORTEDLY FELL OFF THE INFUSION SITE, CAUSING THE CANNULA TO DISLODGE. AS TREATMENT, A NEW POD WAS PLACED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/03/16 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMPremature ActivationHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO OVER 400 MG/DL. THE PATIENT'S FATHER STATED THAT THE CANNULA CAME OUT RIGHT WHEN THE NEEDLE GUARD WAS REMOVED. THE POD WAS NOT WORN. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/21 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH, PODS 10-PACKLoss of or Failure to Bond; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) READ HIGH (>500 MG/DL) WHILE WEARING THE POD. THE POD REPORTEDLY FELL OFF THE INFUSION SITE, CAUSING THE CANNULA TO DISLODGE. AS TREATMENT, A NEW POD WAS PLACED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/03/21 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH, PODS 10-PACKLoss of or Failure to Bond; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) READ HIGH (>500 MG/DL) WHILE WEARING THE POD. THE POD REPORTEDLY FELL OFF THE INFUSION SITE, CAUSING THE CANNULA TO DISLODGE. AS TREATMENT, A NEW POD WAS PLACED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/03/21 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH, PODS 10-PACKLoss of or Failure to Bond; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) READ HIGH (>500 MG/DL) WHILE WEARING THE POD. THE POD REPORTEDLY FELL OFF THE INFUSION SITE, CAUSING THE CANNULA TO DISLODGE. AS TREATMENT, A NEW POD WAS PLACED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/03/16 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMDifficult to Insert; Material Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO ¿HIGH¿ (> 27.8 MMOL/L) (> 500 MG/DL) WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. THE PATIENT REPORTED BEING UNSURE IF THE CANNULA WAS PROPERLY SEATED IN THE INFUSION SITE (LEG) . ONCE THE POD WAS REMOVED CUSTOMER REPORTED THAT THE CANNULA WAS BENT. AS TREATMENT PATIENT WAS ABLE TO ACTIVATE A NEW POD. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THE CANNULA WAS POSSIBLY NOT INSERTED CORRECTLY INTO THE INFUSION SITE AND WAS FOUND BENT. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/12 5:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMUnintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) ROSE TO 22 MMOL/L (396 MG/DL) AND "HIGH" (>27.8 MMOL/L,>500 MG/DL) WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. WHEN THE POD WAS REMOVED, THE PATIENT NOTICED THAT THE CANNULA WAS DISLODGED AT THE INFUSION SITE. AS TREATMENT, A NEW POD WAS APPLIED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE AVAILABLE FOR INVESTIGATION BECAUSE IT WAS DISCARDED BY THE PATIENT. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/14 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMUnintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) ROSE TO 22 MMOL/L (396 MG/DL) AND "HIGH" (>27.8 MMOL/L,>500 MG/DL) WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. WHEN THE POD WAS REMOVED, THE PATIENT NOTICED THAT THE CANNULA WAS DISLODGED AT THE INFUSION SITE. AS TREATMENT, A NEW POD WAS APPLIED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE AVAILABLE FOR INVESTIGATION BECAUSE IT WAS DISCARDED BY THE PATIENT. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/21 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH, PODS 10-PACKLoss of or Failure to Bond; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) READ HIGH (>500 MG/DL) WHILE WEARING THE POD. THE POD REPORTEDLY FELL OFF THE INFUSION SITE, CAUSING THE CANNULA TO DISLODGE. AS TREATMENT, A NEW POD WAS PLACED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/03/21 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH, PODS 10-PACKLoss of or Failure to Bond; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) READ HIGH (>500 MG/DL) WHILE WEARING THE POD. THE POD REPORTEDLY FELL OFF THE INFUSION SITE, CAUSING THE CANNULA TO DISLODGE. AS TREATMENT, A NEW POD WAS PLACED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/03/21 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH, PODS 10-PACKLoss of or Failure to Bond; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) READ HIGH (>500 MG/DL) WHILE WEARING THE POD ON THE LEG. THE POD REPORTEDLY FELL OFF THE INFUSION SITE, CAUSING THE CANNULA TO DISLODGE. AS TREATMENT, A NEW POD WAS PLACED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/03/21 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH, PODS 10-PACKLoss of or Failure to Bond; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) READ HIGH (>500 MG/DL) WHILE WEARING THE POD. THE POD REPORTEDLY FELL OFF THE INFUSION SITE, CAUSING THE CANNULA TO DISLODGE. AS TREATMENT, A NEW POD WAS PLACED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/03/21 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH, PODS 10-PACKLoss of or Failure to Bond; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) READ HIGH (>500 MG/DL) WHILE WEARING THE POD. THE POD REPORTEDLY FELL OFF THE INFUSION SITE, CAUSING THE CANNULA TO DISLODGE. AS TREATMENT, A NEW POD WAS PLACED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/03/16 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 400 MG/DL WHILE WEARING THE POD FOR 10 MINUTES. IN ADDITION THE POD FAILED TO ADHERE AND REPORTEDLY FELL OFF THE INFUSION SITE (LEG), CAUSING THE CANNULA TO DISLODGE. AS TREATMENT, THE PATIENT ADMINISTERED INSULIN VIA A PEN INJECTION. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/21 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH, PODS 10-PACKLoss of or Failure to Bond; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) READ HIGH (>500 MG/DL) WHILE WEARING THE POD. THE POD REPORTEDLY FELL OFF THE INFUSION SITE, CAUSING THE CANNULA TO DISLODGE. AS TREATMENT, A NEW POD WAS PLACED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/03/21 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH, PODS 10-PACKLoss of or Failure to Bond; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) READ HIGH (>500 MG/DL) WHILE WEARING THE POD ON THE LEG. THE POD REPORTEDLY FELL OFF THE INFUSION SITE, CAUSING THE CANNULA TO DISLODGE. AS TREATMENT, A NEW POD WAS PLACED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/03/21 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH, PODS 10-PACKLoss of or Failure to Bond; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) READ HIGH (>500 MG/DL) WHILE WEARING THE POD. THE POD REPORTEDLY FELL OFF THE INFUSION SITE, CAUSING THE CANNULA TO DISLODGE. AS TREATMENT, A NEW POD WAS PLACED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/03/02 5:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) ROSE TO OVER 250 MG/DL WHILE WEARING THE POD BETWEEN 1 AND 4 HOURS. IN ADDITION THE POD FAILED TO ADHERE AND REPORTEDLY FELL OFF THE INFUSION SITE (ARM), CAUSING THE CANNULA TO DISLODGE. AS TREATMENT, THE PATIENT APPLIED A NEW POD. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/18 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMFluid Leak; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 24 MMOL/L (432 MG/DL) WHILE WEARING THE POD BETWEEN 36 AND 48 HOURS. THE PATIENT NOTICED INSULIN LEAKING. WHEN REMOVED FROM THE INFUSION SITE (LEG), THE POD'S CANNULA WAS FOUND TO BE DISLODGED. AS TREATMENT, A NEW POD WAS PLACED. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/18 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN PUMPLoss of or Failure to Bond; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) ROSE TO 20 MMOL/L (360 MG/DL) WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. THE POD REPORTEDLY FELL OFF THE INFUSION SITE (ARM), CAUSING THE CANNULA TO DISLODGE. AS TREATMENT, A NEW POD WAS PLACED AND A CORRECTION BOLUS WAS GIVEN. THE POD WAS DISCARDED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/21 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH, PODS 10-PACKLoss of or Failure to Bond; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) READ HIGH (>500 MG/DL) WHILE WEARING THE POD. THE POD REPORTEDLY FELL OFF THE INFUSION SITE, CAUSING THE CANNULA TO DISLODGE. AS TREATMENT, A NEW POD WAS PLACED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/03/16 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMFailure to Fire No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT THE NEEDLE NEVER DEPLOYED THE CANNULA INTO THE SKIN WHILE WEARING THE POD FOR 24 TO 36 HOURS. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/03/21 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH, PODS 10-PACKLoss of or Failure to Bond; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) READ HIGH (>500 MG/DL) WHILE WEARING THE POD. THE POD REPORTEDLY FELL OFF THE INFUSION SITE, CAUSING THE CANNULA TO DISLODGE. AS TREATMENT, A NEW POD WAS PLACED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/03/21 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH, PODS 10-PACKLoss of or Failure to Bond; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) READ HIGH (>500 MG/DL) WHILE WEARING THE POD ON THE LEG. THE POD REPORTEDLY FELL OFF THE INFUSION SITE, CAUSING THE CANNULA TO DISLODGE. AS TREATMENT, A NEW POD WAS PLACED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/03/20 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) ROSE TO 12-15 MMOL/L (216-270 MG/DL) WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. THE POD REPORTEDLY FELL OFF THE INFUSION SITE (ARM), CAUSING THE CANNULA TO DISLODGE. AS TREATMENT, A NEW POD WAS APPLIED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/21 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH, PODS 10-PACKLoss of or Failure to Bond; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) READ HIGH (>500 MG/DL) WHILE WEARING THE POD. THE POD REPORTEDLY FELL OFF THE INFUSION SITE, CAUSING THE CANNULA TO DISLODGE. AS TREATMENT, A NEW POD WAS PLACED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/03/21 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH, PODS 10-PACKLoss of or Failure to Bond; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) READ HIGH (>500 MG/DL) WHILE WEARING THE POD. THE POD REPORTEDLY FELL OFF THE INFUSION SITE, CAUSING THE CANNULA TO DISLODGE. AS TREATMENT, A NEW POD WAS PLACED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/03/17 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMMaterial Twisted/Bent; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE BG) READ "HIGH" (>27.8 MMOL/L) (>500MG/DL) WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. WHEN REMOVED FROM THE INFUSION SITE (HIP/BUTTOCKS), THE POD'S CANNULA WAS FOUND TO BE DISLODGED AND BENT. AS TREATMENT, A NEW POD WAS APPLIED. Manufacturer Narrative: IT WAS REPORTED THAT THE CANNULA WAS BENT AND HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/21 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH, PODS 10-PACKLoss of or Failure to Bond; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) READ HIGH (>500 MG/DL) WHILE WEARING THE POD. THE POD REPORTEDLY FELL OFF THE INFUSION SITE, CAUSING THE CANNULA TO DISLODGE. AS TREATMENT, A NEW POD WAS PLACED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/03/21 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH, PODS 10-PACKLoss of or Failure to Bond; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) READ HIGH (>500 MG/DL) WHILE WEARING THE POD ON THE LEG. THE POD REPORTEDLY FELL OFF THE INFUSION SITE, CAUSING THE CANNULA TO DISLODGE. AS TREATMENT, A NEW POD WAS PLACED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/03/21 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH, PODS 10-PACKLoss of or Failure to Bond; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) READ HIGH (>500 MG/DL) WHILE WEARING THE POD ON THE LEG. THE POD REPORTEDLY FELL OFF THE INFUSION SITE, CAUSING THE CANNULA TO DISLODGE. AS TREATMENT, A NEW POD WAS PLACED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2021/10/18 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 500 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. WHEN REMOVED FROM THE INFUSION SITE (ABDOMEN), THE POD'S CANNULA WAS FOUND BENT. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2011/01/01 5:00:00InjuryINSULET CORPORATIONOMNIPOD INSULIN PUMPInsufficient InformationHyperglycemia; Nausea; Vomiting; ComaEvent Description: IT WAS REPORTED THAT THE PATIENT HAD BEEN HOSPITALIZED WITH HYPERGLYCEMIA AND PANCREATITIS. THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED OVER 800 MG/DL WHILE WEARING THE POD BETWEEN 36 AND 48 HOURS. SYMPTOMS REPORTED INCLUDE NAUSEA, VOMITING AND DISORIENTATION; HE DESCRIBED HIMSELF AS "BEING IN A COMA" PRIOR TO GOING TO HOSPITAL. PATIENT WAS RUSHED BY AMBULANCE TO THE HOSPITAL AND WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU). THE POD WAS REMOVED AT THE HOSPITAL AND PATIENT DOES NOT RECALL METHOD OF TREATMENT AS THIS MEDICAL EVENT OCCURRED 11 YEARS AGO. HE SPENT ONE WEEK IN THE HOSPITAL, THE FIRST 4 DAYS WERE SPENT IN THE ICU. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED HOSPITALIZATION AND HYPERGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED. HIGH BLOOD GLUCOSE IS A COMMON SYMPTOM FOR PEOPLE WITH DIABETES (GLUCOSE MONITORING DATA FROM PEOPLE WITH DIABETES INDICATE THAT ON AVERAGE, THEY CAN EXPERIENCE BLOOD GLUCOSE LEVELS ABOVE 250 MG/DL FOR 14-25% OF THE TIME[1][2][3]), AND IT WOULD BE CHALLENGING TO SPECULATE ON A CAUSE FOR THE COMPLAINTS WITHOUT RECEIVING THE DEVICES BACK FOR AN ENGINEERING INVESTIGATION. BECK RW, BERGENSTAL RM, CHENG P, KOLLMAN C, CARLSON AL, JOHNSON ML, RODBARD D. THE RELATIONSHIPS BETWEEN TIME IN RANGE, HYPERGLYCEMIA METRICS, AND HBA1C. J DIABETES SCI TECHNOL 2019;13:614-626. WELSH JB, DERDZINSKI M, PARKER AS, PUHR S, JIMENEZ A, WALKER T. REAL-TIME SHARING AND FOLLOWING OF CONTINUOUS GLUCOSE MONITORING DATA IN YOUTH. DIABETES THER 2019;10:751-755. PUHR S, DERDZINSKI M, WELSH JB, PARKER AS, WALKER T, PRICE DA. REAL-WORLD HYPOGLYCEMIA AVOIDANCE WITH A CONTINUOUS GLUCOSE MONITORING SYSTEM'S PREDICTIVE LOW GLUCOSE ALERT. DIABETES TECHNOL THER 2019;21:155-158. PATIENT STATED U-200 INSULIN WAS USED WITH THE OMNIPOD SYSTEM WHICH IS CONSIDERED OFF-LABEL USE. THE MARKETED AND RELEASED DEVICE IS ONLY INTENDED TO BE USED WITH U-100 INSULIN. THIS USER WARNING IS IN THE APPLICABLE LABELING AS REFERENCED BELOW: OMNIPOD INSULIN MANAGEMENT SYSTEM ¿ USER GUIDE, MODEL: UST400 14421-AW REV H 01/16 INTRODUCTION / PAGE X. WARNING: THE OMNIPOD SYSTEM IS DESIGNED TO USE RAPID-ACTING U-100 INSULIN. THE FOLLOWING U-100 RAPID-ACTING INSULIN ANALOGS HAVE BEEN TESTED AND FOUND TO BE SAFE FOR USE IN THE POD: NOVOLOG®/NOVORAPID®, HUMALOG®, OR APIDRA®. NOVOLOG® IS COMPATIBLE WITH THE OMNIPOD SYSTEM FOR USE UP TO 72 HOURS (3 DAYS). BEFORE USING A DIFFERENT INSULIN WITH THE OMNIPOD SYSTEM, CHECK THE INSULIN DRUG LABEL TO MAKE SURE IT CAN BE USED WITH A PUMP. REFER TO THE INSULIN LABELING AND FOLLOW YOUR HEALTHCARE PROVIDER¿S DIRECTIONS FOR HOW OFTEN TO REPLACE THE POD.
2022/01/06 5:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) ROSE TO 24 MMOL/L (432 MG/DL) WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. THE POD REPORTEDLY WAS COMING LOOSE FROM THE INFUSION SITE (ABDOMEN), CAUSING THE CANNULA TO DISLODGE. AS TREATMENT, A NEW POD WAS PLACED. THE POD WAS DISCARDED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE AVAILABLE FOR INVESTIGATION BECAUSE IT WAS DISCARDED BY THE PATIENT. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/21 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH, PODS 10-PACKLoss of or Failure to Bond; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) READ HIGH (>500 MG/DL) WHILE WEARING THE POD ON THE LEG. THE POD REPORTEDLY FELL OFF THE INFUSION SITE, CAUSING THE CANNULA TO DISLODGE. AS TREATMENT, A NEW POD WAS PLACED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/01/09 5:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) ROSE TO 24 MMOL/L (432 MG/DL) WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. THE POD REPORTEDLY WAS COMING LOOSE FROM THE INFUSION SITE (ABDOMEN), CAUSING THE CANNULA TO DISLODGE. AS TREATMENT, A NEW POD WAS PLACED. THE POD WAS DISCARDED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE AVAILABLE FOR INVESTIGATION BECAUSE IT WAS DISCARDED BY THE PATIENT. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/02/22 5:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMPremature Activation No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THE NEEDLE MECHANISM FULLY DEPLOYED BEFORE THE POD WAS ABLE TO BE USED. THE POD WAS NOT WORN AND NO ADVERSE PATIENT IMPACT WAS REPORTED. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/02/27 5:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMInsufficient InformationHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENTS BLOOD GLUCOSE LEVEL ROSE TO 346 MG/DL WHILE WEARING THE POD BETWEEN 1 AND 4 HOURS. AS TREATMENT, A NEW POD WAS APPLIED. Manufacturer Narrative: THE DEVICE WAS RECEIVED DEPLOYED. INSPECTION OF THE DEVICE DISCOVERED A TORN SOFT CANNULA. THE TORN SOFT CANNULA MEASURED OUT TO BE 0.603" FROM THE NAIL HEAD, WHICH IS OUT OF SPECIFICATION. THE SHORTENED SOFT CANNULA EXPLAINS WHY THE SOFT CANNULA WAS NOT OBSERVED IN THE BOTTOM HOUSING VIEWING WINDOW. THE DAMAGE OBSERVED INCLUDED THE EXPOSED AND SOME OF THE UNEXPOSED PORTION OF THE SOFT CANNULA, JUST BEFORE THE TIP OF THE FORMED NEEDLE. FLUID WAS NOT ABLE TO PROPERLY FLOW THROUGH AND COMPLETE THE FLUID PATH DUE TO THE DAMAGE CREATED BY THE TEAR, THE DAMAGE WHICH REMOVED THE DISTAL TIP AND CROSS DRILL OF THE SOFT CANNULA ENTIRELY. HOWEVER, THE DOWNLOADED DATA DID NOT SHOW ANY TIMEOUTS OR DRIVE STALLS THAT COULD INDICATE A FAILURE OF THE DEVICE TO DELIVER INSULIN. ALTHOUGH DAMAGE WAS OBSERVED ON THE EXPOSED AND SOME OF THE UNEXPOSED PORTION OF THE SOFT CANNULA, THE TIMING AND CAUSE COULD NOT BE DETERMINED.
2022/03/16 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMFailure to FireHyperglycemiaEvent Description: IT WAS REPORTED BY THE PATIENT THAT WHEN THEY WERE ACTIVATING THE POD THEY DID NOT FEEL THE NEEDLE NOR THE CANNULA INSERTING. AFTER REMOVING THE POD IT WAS DISCOVERED THAT THE CANNULA DID NOT DEPLOY. THE PATIENTS BLOOD GLUCOSE LEVEL WAS AROUND 261 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/09 5:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMPremature ActivationHyperglycemiaEvent Description: IT WAS REPORTED THE NEEDLE DEPLOYED EARLY, INDICATING A FAILURE OF THE NEEDLE MECHANISM. THE PATIENT'S BLOOD GLUCOSE LEVELS ROSE UP TO 17.2 MMOL/L (309.6 MG/DL) AND THE POD WAS NOT WORN. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/03/17 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) ROSE TO 300 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. THE POD REPORTEDLY WAS COMING LOOSE FROM THE INFUSION SITE (ARM), CAUSING THE CANNULA TO DISLODGE. AS TREATMENT, A NEW POD WAS APPLIED. THE POD WAS DISCARDED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/17 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN PUMPFluid Leak; Material Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE ABOVE 400 MG/DL WHILE WEARING THE POD LONGER THAN 48 HOURS. THE POD WAS LEAKING INSULIN FROM THE INFUSION SITE (ARM), WHEN REMOVED THE POD'S CANNULA WAS FOUND BENT. AS TREATMENT, A NEW POD WAS APPLIED. THE POD WAS DISCARDED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/01/30 5:00:00InjuryINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMInsufficient InformationScar TissueEvent Description: IT WAS REPORTED WHILE A PATIENT HAD WORN A POD FOR LESS THAN AN HOUR THE POD WAS BLEEDING. UPON REMOVAL OF THE POD FROM THE INFUSION SITE, (ARM) THE POD WAS FOUND TO HAVE LEFT A SCAR. AS TREATMENT, THE PATIENT APPLIED A NEW POD. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE SKIN SCARRING. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. THE OMNIPOD IS ISO10993 COMPLIANT, UNDERGOING CYTOTOXICITY, SENSITIZATION, GENOTOXICITY, HEMOLYSIS, IRRITATION OR INTRACUTANEOUS REACTIVITY, SYSTEMIC TOXICITY, AND IMPLANTATION EFFECTS TESTING. THE OMNIPOD IS STERILIZED WITH 100% ETHYLENE OXIDE GAS WITH A STERILITY ASSURANCE LEVEL OF 10-6  PER ISO11135  AND EO RESIDUAL LEVELS IN COMPLIANCE WITH ISO10993. EACH LOT  IS CONFIRMED TO MEET REQUIREMENTS FOR NON-PYROGENICITY PER ISO10993 AND STERILITY PER ISO11135 PRIOR TO RELEASE.
2022/03/23 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMFailure to Fire No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THE PINK SLIDE DID NOT MOVE FORWARD AND THE CANNULA WAS NOT VISIBLE; INDICATING THE NEEDLE MECHANISM DID NOT DEPLOY. THE POD WAS NOT WORN AND NO ADVERSE PATIENT IMPACT WAS REPORTED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/24 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH, PODS 10-PACKFailure to Fire No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THE PINK SLIDE DID NOT MOVE FORWARD AND THE CANNULA WAS NOT VISIBLE; INDICATING THE NEEDLE MECHANISM DID NOT DEPLOY. THE POD WAS NOT WORN AND NO ADVERSE PATIENT IMPACT WAS REPORTED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/02/24 5:00:00InjuryINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMInsufficient InformationHyperglycemia; VomitingEvent Description: IT WAS REPORTED THAT THE PATIENT VISITED THE EMERGENCY ROOM (ER) DUE TO HIGH BLOOD GLUCOSE (BG) LEVELS OF 26 MMOL/L (468 MG/DL) KETONES AND VOMITING, WHILE WEARING THE POD ON THE LEG BETWEEN 24 AND 36 HOURS. AT THE HOSPITAL, THE PATIENT WAS ADMINISTERED MANUAL INSULIN INJECTIONS. THE POD WAS DISCARDED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED ER VISIT AND HYPERGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/03/03 5:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM Activation, Positioning or SeparationProblemHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVEL REACHED 20 MMOL/L (360 MG/DL) WITH KETONES OF 1.2. THE POD WAS WORN BETWEEN 4 AND 24 HOURS ON THE LEG. IT WAS NOTED THAT THE PINK SLIDE DID NOT MOVE FORWARD, BUT THE CANNULA WAS VISIBLE. HYPERGLYCEMIA TREATED WITH A NEW POD AND CORRECTIONAL BOLUS. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/16 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMFailure to Fire No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THE NEEDLE DID NOT DEPLOY. THE POD WAS NOT WORN AND NO ADVERSE PATIENT IMPACT WAS REPORTED. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/20 4:00:00InjuryINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMFailure to Power UpHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT HAD BEEN HOSPITALIZED WITH HYPERGLYCEMIA. IT WAS NOTED THAT THE OMNIPOD PERSONAL DIABETES MANAGER (PDM) WILL NOT TURN ON AND FAILED DURING THE NIGHT. THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 40 MMO/L (720 MG/DL). THE PATIENT WAS TREATED WITH INSULIN AND WAS RELEASED THE FOLLOWING DAY. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED HOSPITALIZATION AND HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/20 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMFluid Leak; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS EXCEEDED 400 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. THE POD WAS LEAKING INSULIN. THE CANNULA DISLODGED FROM THE INFUSION SITE. AS TREATMENT FOR HYPERGLYCEMIA, A MANUAL INJECTION OF INSULIN WAS DELIVERED AND A NEW POD WAS APPLIED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/03/20 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMFluid Leak; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS EXCEEDED 400 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. THE POD WAS LEAKING INSULIN. THE CANNULA DISLODGED FROM THE INFUSION SITE. AS TREATMENT FOR HYPERGLYCEMIA, A MANUAL INJECTION OF INSULIN WAS DELIVERED AND A NEW POD WAS APPLIED. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/ RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/23 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED OVER 300 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. WHEN REMOVED FROM THE INFUSION SITE (ABDOMEN), THE POD'S CANNULA WAS FOUND BENT. AS TREATMENT, INSULIN WAS DELIVERED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/20 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMPremature Activation No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED BY THE PATIENT THAT THEY HAD A POD WHERE THE NEEDLE DEPLOYED EARLY BEFORE THE POD WAS APPLIED. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/23 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemia; Pain; Swelling/ EdemaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED OVER 400 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. WHEN REMOVED FROM THE INFUSION SITE (ARM), THE POD'S CANNULA WAS FOUND BENT. PAIN AND SWELLING AT THE SITE WAS ALSO REPORTED. AS TREATMENT, A MANUAL INJECTION OF INSULIN WAS DELIVERED. THIS POD WAS DISCARDED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/01/06 5:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED OVER 300 MG/DL WHILE WEARING THE POD. WHEN REMOVED FROM THE INFUSION SITE (ABDOMEN), THE POD'S CANNULA WAS FOUND BENT. AS TREATMENT, INSULIN WAS DELIVERED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/20 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMFluid Leak; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS EXCEEDED 400 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. THE POD WAS LEAKING INSULIN. THE CANNULA DISLODGED FROM THE INFUSION SITE. AS TREATMENT FOR HYPERGLYCEMIA, A MANUAL INJECTION OF INSULIN WAS DELIVERED AND A NEW POD WAS APPLIED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/03/11 5:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMFailure to Fire No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THE CANNULA DID NOT DEPLOY, INDICATING A FAILURE OF THE NEEDLE MECHANISM. THE PATIENT'S BLOOD GLUCOSE LEVELS WERE UNAFFECTED, AND THE POD WAS NOT WORN. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/16 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMFailure to Fire No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THE NEEDLE DID NOT DEPLOY. THE POD WAS NOT WORN AND NO ADVERSE PATIENT IMPACT WAS REPORTED. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/17 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD INSULIN MANAGEMENT SYSTEMFluid Leak; Material Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE ABOVE 400 MG/DL WHILE WEARING THE POD LONGER THAN 48 HOURS. THE POD WAS LEAKING INSULIN FROM THE INFUSION SITE (LEG), WHEN REMOVED THE POD'S CANNULA WAS FOUND BENT. AS TREATMENT, A NEW POD WAS APPLIED. THE POD WAS DISCARDED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/19 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMPremature Activation No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THE NEEDLE MECHANISM FULLY DEPLOYED BEFORE THE POD WAS ABLE TO BE USED. THE POD WAS NOT WORN AND NO ADVERSE PATIENT IMPACT WAS REPORTED. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/23 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMFailure to FireHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT FOUND CANNULA HAD NOT DEPLOYED AS INTENDED. THE CANNULA WAS NOT VISIBLE AND THE PINK SLIDE DID NOT MOVE FORWARD, INDICATING A NEEDLE MECHANISM FAILURE. THE PATIENT'S BLOOD GLUCOSE (BG) VALUES REACHED 400 MG/DL. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/23 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMDifficult or Delayed Activation No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT THE NEEDLE MECHANISM HAD A DELAYED DEPLOYMENT AND THE POD WAS UNABLE TO BE USED. THE PATIENT'S BLOOD GLUCOSE (BG) VALUES REACHED 126 MG/DL. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/20 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMFailure to FireHyperglycemiaEvent Description: IT WAS REPORTED BY THE PATIENT THAT THE CANNULA DID NOT DEPLOY OR INSERT AS INTENDED DURING ACTIVATION. THE PINK SLIDE WAS NOT FORWARD, INDICATING A NEEDLE MECHANISM FAILURE. BLOOD GLUCOSE LEVELS REACHED 367 MG/DL. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/18 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMLoss of or Failure to Bond; Unintended MovementHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 400 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. PATIENT STATED THE POD FELL OFF AND THE CANNULA DISLODGED FROM THE INFUSION SITE (ARM). AS TREATMENT, A NEW POD WAS APPLIED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
2022/03/19 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMFailure to Fire No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THE CANNULA DID NOT DEPLOY; INDICATING THE NEEDLE MECHANISM DID NOT FUNCTION AS INTENDED. THE POD WAS NOT WORN AND NO ADVERSE PATIENT IMPACT WAS REPORTED. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/20 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMPremature ActivationHyperglycemiaEvent Description: IT WAS REPORTED BY THE PATIENT THAT THEY HAD A POD WHERE THE NEEDLE DEPLOYED EARLY BEFORE THE POD WAS APPLIED. BLOOD GLUCOSE LEVELS REACHED 335 MG/DL. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/23 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT A PATIENT'S BLOOD GLUCOSE LEVELS (BG) REACHED ALMOST 500 MG/DL WHILE WEARING THE POD BETWEEN 1 AND 4 HOURS. THE PATIENT REPORTED CANNULA BEING BENT WHILE WEARING IT ON THE ARM. FOR TREATMENT, THE PATIENT CHANGED OUT THE POD AND GAVE CORRECTION BOLUSES. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/ RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/19 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMUnintended MovementHyperglycemia; Skin Inflammation/ IrritationEvent Description: IT WAS REPORTED THAT A PATIENT'S BLOOD GLUCOSE LEVELS (BG) REACHED OVER 400 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. THE PATIENT REPORTED CANNULA BEING DISLODGED, WHILE WEARING IT ON THE ARM. FOR TREATMENT, THE PATIENT GAVE CORRECTION BOLUSES. THE POD WAS DISCARDED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/22 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMFailure to Fire No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT THE PATIENT FOUND CANNULA HAD NOT DEPLOYED AS INTENDED. THE CANNULA WAS NOT VISIBLE AND THE PINK SLIDE DID NOT MOVE FORWARD, INDICATING A NEEDLE MECHANISM FAILURE. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/23 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMFailure to FireHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT FOUND CANNULA HAD NOT DEPLOYED AS INTENDED. THE CANNULA WAS NOT VISIBLE AND THE PINK SLIDE DID NOT MOVE FORWARD, INDICATING A NEEDLE MECHANISM FAILURE. THE PATIENT'S BLOOD GLUCOSE (BG) VALUES REACHED 400 MG/DL. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/18 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMPremature Activation No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT THE NEEDLE DEPLOYED EARLY WHEN THE POD WAS ACTIVATED; THIS INDICATES A NEEDLE MECHANISM FAILURE OCCURRED. THE POD WAS NOT WORN AND WAS DISCARDED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/20 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMUnintended MovementHyperglycemia; Skin Inflammation/ IrritationEvent Description: IT WAS REPORTED THAT A PATIENT'S BLOOD GLUCOSE LEVELS (BG) REACHED OVER 400 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. THE PATIENT REPORTED CANNULA BEING DISLODGED, WHILE WEARING IT ON THE ARM. FOR TREATMENT, THE PATIENT GAVE CORRECTION BOLUSES. THE POD WAS DISCARDED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/18 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMUnintended MovementHyperglycemia; Skin Inflammation/ IrritationEvent Description: IT WAS REPORTED THAT A PATIENT'S BLOOD GLUCOSE LEVELS (BG) REACHED OVER 400 MG/DL WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. THE PATIENT REPORTED CANNULA BEING DISLODGED, WHILE WEARING IT ON THE ARM. FOR TREATMENT, THE PATIENT GAVE CORRECTION BOLUSES. THE POD WAS DISCARDED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/23 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMDifficult or Delayed Activation No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT THE NEEDLE DEPLOYED LATE WHEN THE POD WAS ACTIVATED; THIS INDICATES A NEEDLE MECHANISM FAILURE OCCURRED. THE POD WAS NOT WORN. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/23 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMFailure to Fire No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT THE CANNULA DID NOT DEPLOY WHEN THE POD WAS ACTIVATED; THIS INDICATES A NEEDLE MECHANISM FAILURE OCCURRED. THE POD WAS WORN LESS THAN ONE HOUR. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.
2022/03/19 4:00:00InjuryINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMAdverse Event Without Identified Device or Use ProblemHyperglycemia; Diabetic KetoacidosisEvent Description: IT WAS REPORTED THAT THE PATIENT WENT TO THE EMERGENCY ROOM (ER) AND WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS. THE PATIENT'S BLOOD GLUCOSE (BG) VALUES REACHED OVER 500 MG/DL. FOR TREATMENT, THE PATIENT RECEIVED INTRAVENOUS (IV) INSULIN AND SALINE DRIPS. THE POD WAS WORN BETWEEN 36 AND 48 HOURS ON THE LEG. THE PATIENT WAS DISCHARGED AFTER 1 DAY. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED HOSPITALIZATION AND DIABETIC KETOACIDOSIS. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS. HIGH BLOOD GLUCOSE IS A COMMON SYMPTOM FOR PEOPLE WITH DIABETES (GLUCOSE MONITORING DATA FROM PEOPLE WITH DIABETES INDICATE THAT ON AVERAGE, THEY CAN EXPERIENCE BLOOD GLUCOSE LEVELS ABOVE 250 MG/DL FOR 14-25% OF THE TIME[1][2][3]), AND IT WOULD BE CHALLENGING TO SPECULATE ON A CAUSE FOR THE COMPLAINTS WITHOUT RECEIVING THE DEVICES BACK FOR AN ENGINEERING INVESTIGATION. BECK RW, BERGENSTAL RM, CHENG P, KOLLMAN C, CARLSON AL, JOHNSON ML, RODBARD D. THE RELATIONSHIPS BETWEEN TIME IN RANGE, HYPERGLYCEMIA METRICS, AND HBA1C. J DIABETES SCI TECHNOL 2019;13:614-626. WELSH JB, DERDZINSKI M, PARKER AS, PUHR S, JIMENEZ A, WALKER T. REAL-TIME SHARING AND FOLLOWING OF CONTINUOUS GLUCOSE MONITORING DATA IN YOUTH. DIABETES THER 2019;10:751-755. PUHR S, DERDZINSKI M, WELSH JB, PARKER AS, WALKER T, PRICE DA. REAL-WORLD HYPOGLYCEMIA AVOIDANCE WITH A CONTINUOUS GLUCOSE MONITORING SYSTEM'S PREDICTIVE LOW GLUCOSE ALERT. DIABETES TECHNOL THER 2019;21:155-158.
2022/01/30 5:00:00InjuryINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMInsufficient InformationPurulent Discharge; Hyperglycemia; Skin Inflammation/ Irritation; Swelling/ EdemaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS ROSE TO 280 MG/DL WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. WHEN REMOVED FROM THE INFUSION SITE (BACK), THE PATIENT NOTICED IRRITATION, SWELLING AND INFLAMMATORY PUS NOTED AT THE SITE. THE PATIENT CONTACTED THEIR DOCTOR AND WAS TOLD TO USED AN UNKNOWN CREAM WHICH THE PATIENT DID NOT USE BUT INSTEAD TREATED WITH LAVENDER ON AN HERBAL BASIS CREAM. AS TREATMENT FOR HIGH BGS, THE PATIENT PLACED A NEW POD. DURING A FOLLOW UP CALL ON 21MAR2022, THE PATIENT REPORTED THAT THEIR DOCTOR PRESCRIBED AN ANTIBIOTIC CREAM TO TREAT THE IRRITATION. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE SKIN IRRITATION. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. THE OMNIPOD IS ISO10993 COMPLIANT, UNDERGOING CYTOTOXICITY, SENSITIZATION, GENOTOXICITY, HEMOLYSIS, IRRITATION OR INTRACUTANEOUS REACTIVITY, SYSTEMIC TOXICITY, AND IMPLANTATION EFFECTS TESTING. THE OMNIPOD IS STERILIZED WITH 100% ETHYLENE OXIDE GAS WITH A STERILITY ASSURANCE LEVEL OF 10-6  PER ISO11135  AND EO RESIDUAL LEVELS IN COMPLIANCE WITH ISO10993. EACH LOT  IS CONFIRMED TO MEET REQUIREMENTS FOR NON-PYROGENICITY PER ISO10993 AND STERILITY PER ISO11135 PRIOR TO RELEASE.
2022/03/17 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMUnintended MovementHyperglycemia; Skin Inflammation/ IrritationEvent Description: IT WAS REPORTED THAT A PATIENT'S BLOOD GLUCOSE LEVELS (BG) REACHED OVER 400 MG/DL WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. THE PATIENT REPORTED CANNULA BEING DISLODGED, WHILE WEARING IT ON THE ARM. FOR TREATMENT, THE PATIENT GAVE CORRECTION BOLUSES. THE POD WAS DISCARDED. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.
2022/03/18 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMMaterial Twisted/BentHyperglycemiaEvent Description: IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 320 MG/DL WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. WHEN REMOVED FROM THE INFUSION SITE (LEG), THE POD'S CANNULA WAS FOUND BENT. AS TREATMENT FOR HYPERGLYCEMIA, A MANUAL INJECTION OF INSULIN WAS DELIVERED AND A NEW POD WAS APPLIED. Manufacturer Narrative: THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.
2022/03/19 4:00:00MalfunctionINSULET CORPORATIONOMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEMFailure to Fire No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT THE NEEDLE DID NOT DEPLOY. Manufacturer Narrative: ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.
the FDA receives several hundred thousand medical device reports (MDRs) of suspected device-associated deathsserious injuries and malfunctions. The FDA uses MDRs to monitor device performancedetect potential device-related safety issuespatients and consumers.
inaccurateuntimelyunverifiedMDRs comprise only one of the FDA's several important postmarket surveillance data sources.
or frequency of problems associated with devices. Confirming whether a device actually caused a specific event can be difficult based solely on information provided in a given report. Establishing a cause-and-effect relationship is especially difficult if circumstances surrounding the event have not been verified or if the device in question has not been directly evaluated.
user facilityimporterdistributor
"(b)(4)" may be found in place of the product's composition and "(b)(6)" may be found in place of a patient's age. MAUDE is updated monthly and the search page reflects the date of the most recent update. The FDA seeks to include all reports received prior to the update but the inclusion of some reports may be delayed.
if known. Serious injury reports must be sent to the manufacturer or to the FDAif the manufacturer is not known.

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