The Diabetic Format

The thrust for this site and community is to provide information that can help individuals make informed decisions regarding diabetic care. Each week, it’s a lofty goal at this point, we will update the detail for manufacturers in the diabetic space. All of the data on this site is called from publicly available APIs.  We can’t guarantee the accuracy of the data as we are not the source.  Currently, the data is all called from the FDA’s MAUDE database.  You can learn more about MAUDE here.
Learn. Bench Test assessment
As a chemical engineer myself, I found this study on insulin pumps to be very informative and valuable. https://www.iamdiabetic.eu/storage/38/fc8457bd-all-insulin-pums-are-not-equivalent-a-bench-test-assessment-for-several-basal-rates.pdf
Learn.  MAUDE
At the highest level, Omnipod (vs. Tandem and Medtronic) appears to have the highest rates of malfunction and injury.  It’s important to consider how a disposable insulin pump has greater opportunity for to be reported because there are more devices being utilized.
Leearn.  Company Culture
While this report is six years old, we believe the information is still relevant and an important consideration about their culture: https://seekingalpha.com/article/4026931-insulet-investors-being-kept-in-dark-ceo-alleged-to-encourage-questionable-sales-techniques https://www.yahoo.com/news/report-questions-insulet-managements-baseless-151607484.html
:earn. Maude
There does appear to be more complaints of infusion site infections and the related versus both Tandem and Medtronic. At high level it also appears there are more instances of over delivery. We will keep reporting about issues here.  
Omnipod FDA MAUDE data Jan 2019 thru March 2022
Patient Reported ProblemNumber of Reported Problems
Abdominal Pain40
Abscess118
Anemia2
Asthma2
Bacterial Infection55
Blood Loss4
Bronchitis2
Bruise/Contusion150
Burn(s)2
Burning Sensation13
Cardiac Arrest6
Cardiopulmonary Arrest5
Cellulitis96
Chest Pain59
Coma2
Confusion/ Disorientation1
Contact Dermatitis2
Convulsion/Seizure1
Cyst(s)5
Death54
Dehydration202
Diabetic Ketoacidosis143
Diarrhea17
Dizziness1
Dyspnea1
Edema3
Erythema3
Extreme Exhaustion2
Fainting8
Fall2
Fatigue31
Fever19
Headache71
Hematoma8
High Blood Pressure/ Hypertension2
Hyperglycemia26767
Hypersensitivity/Allergic reaction23
Hypoglycemia433
Inflammation1
Insufficient Information108
Irritability1
Irritation130
Itching Sensation69
Loss of consciousness3
Nausea20
No Clinical Signs, Symptoms or Conditions3692
No Consequences Or Impact To Patient1
No Information4232
No Known Impact Or Consequence To Patient3
Pain215
Purulent Discharge204
Rash19
Reaction5
Renal Failure2
Scar Tissue5
Seizures2
Sepsis1
Skin Discoloration1
Skin Infection51
Skin Inflammation/ Irritation61
Skin Irritation65
Staphylococcus Aureus2
Stroke/CVA2
Unspecified Infection212
Vomiting37
Weakness1
Problem Left Blank1000
Total Number 38552
Omnipod Data from Maude from January 2019 thru March 2022
Reported Death Details 
Death54
(B)(6), A NURSE FROM (B)(6) HOSPITAL CALLED TO REPORTED THAT A PATIENT WHO IS ON THE OMNIPOD SYSTEM HAD PASSED AWAY ON (B)(6) 2020. THE LAST KNOWN BLOOD GLUCOSE READING WAS NOTED AT 20.4 MMOL/L (367.6 MG/DL) ON (B)(6) 2020. THERE WAS NO FURTHER INFORMATI1
A DIABETES NURSE REPORTED THAT THE PATIENT PASSED AWAY IN A FATAL MOTORCYCLE ACCIDENT AROUND 18:00 ON (B)(6) 2019. THE FORENSIC DOCTOR HAD REQUESTED THE DIABETES NURSE TO INVESTIGATE THE OMNIPOD PRODUCT AS THE INVESTIGATION NOTICED THAT THE PATIENT HAD L1
COMPLAINT WAS REPORTED VIA SOCIAL MEDIA - (B)(6) POSTING STATES: "BE CAREFUL WITH THESE. I'M 100% POSITIVE A DEFECTIVE POD KILLED MY HUSBAND. THE PODS KEPT ALARMING ERROR OUT FOR ABOUT 3 WEEKS BEFORE HE DIED THEY WERE RELEASING TOO MUCH INSULIN SO HE HAD1
IT WAS REPORTED BY A PATIENTS WIFE THAT THE PATIENT HAS PASSED AWAY. THE WIFE WANTED TO KNOW IF SHE CAN RETURN ANY UNUSED PRODUCTS. THE PATIENTS WIFE STATED THAT HE HAS BEEN SICK AND OFF OF OUR PRODUCTS AND HAS NOT USED OMNIPOD FOR A WHILE. THREE ATTEMPTS TO REACH OUT TO THE WIFE WERE MADE. NO ADDITIONAL INFORMATION WAS ABLE TO BE OBTAINED. AN MDR WILL BE FILED OUT OF CAUTION FOR WE ARE UNAWARE IF OUR PRODUCT WAS BEING WORN AT THE TIME OF DEATH.1
IT WAS REPORTED BY THE NIECE THAT THE PATIENT PASSED AWAY AT THEIR HOME. THE NIECE STATED THAT IT WAS DUE TO DIABETES, BUT REFUSED TO ELABORATE ON DETAILS. THE PATIENT WAS REPORTED TO HAVE BEEN USING OMNIPOD SYSTEM FOR ONLY 5 DAYS PRIOR TO THEIR DEATH. THE PATIENT WAS SCHIZOPHRENIC AND BIPLOAR AND WAS TAKEN UP TO 6 DIFFERENT UNKNOWN MEDICATIONS.1
IT WAS REPORTED BY THE PATIENT'S WIFE THAT HER HUSBAND HAS PASSED AWAY ON (B)(6) 2019. THERE WAS NO ADDITIONAL INFORMATION ON THIS EVENT. ATTEMPTS WAS MADE TO CONTACT THE PATIENT'S WIFE TO OBTAIN ADDITIONAL INFORMATION ABOUT THE EVENT, BUT THERE WAS NO ANSWER, SO A VOICE MESSAGE WAS LEFT TO CALL US BACK.1
IT WAS REPORTED BY THE PATIENTS WIFE THAT THE PATIENT WAS IN THE HOSPITAL FOR SIX WEEKS PRIOR TO HIS PASSING HOWEVER NO OTHER DETAILS WERE PROVIDED ON THE EVENT.1
IT WAS REPORTED BY THE SPOUSE, THAT THE PATIENT RECEIVED TOO MUCH INSULIN AND PASSED AWAY. THE PATIENT WAS SUFFERING FROM ANXIETY AND DEPRESSION. THE PATIENT PASSED AWAY AT HOME. THE PATIENT'S BLOOD GLUCOSE (BG) VALUES WERE BELOW 70 MG/DL. NO FURTHER DETAILS TO REPORT.1
IT WAS REPORTED BY THE TECH COORDINATOR THAT THEY GOT A CALL FROM THE PATIENT'S SISTER THAT THE PATIENT WAS FOUND DECEASED IN HER HOME BY POLICE. THE CAUSE OF DEATH WAS UNKNOWN. WE HAVE BEEN UNABLE TO OBTAIN ANY NEW INFORMATION REGARDING THE PATIENT'S DEATH.1
IT WAS REPORTED THAT A PATIENT CALLED IN AND MENTIONED HIS FRIEND HAD DIED DUE TO THE PRODUCT. THE UNKNOWN PATIENT WAS VERY NEW TO BEING DIAGNOSED WITH DIABETES AND WAS ON THE POD SYSTEM FOR 1 OR 2 MONTHS. THE DAY BEFORE SHE HAD PASSED AWAY, SHE CHECKED HER BLOOD GLUCOSE BEFORE GOING TO SLEEP AND THE RESULTS WERE 163 MG/DL. THE NEXT MORNING SHE WAS FOUND DEAD. SHE NEVER BOLUSED, ONLY USED THE BASAL SETTINGS. THE REPORTER DID NOT KNOW THE SPECIFIC DAY SHE HAD PASSED, NOR REMEMBER THE DATE, AND DID NOT HAVE ANY OTHER SPECIFIC INFORMATION ABOUT HIS FRIEND WHO PASSED.1
IT WAS REPORTED THAT A PATIENT DIED AT HOME ON (B)(6) 2019. THE CAUSE OF DEATH IS NOT CLEAR AS THE PERSON REPORTING THE CASE DID NOT HAVE MUCH INFORMATION OF THE EVENT, BUT STATED IT WAS POSSIBLY A HEART ATTACK.1
IT WAS REPORTED THAT A PATIENT DIED FROM A HEART ATTACK AFTER LEAVING THE HOSPITAL FROM BACK SURGERY. THE PATIENT NEEDED A KIDNEY TRANSPLANT BUT IT IS UNKNOWN IF THE PATIENT WAS USING THE POD AT THE TIME OF DEATH.1
IT WAS REPORTED THAT A PATIENT EXPIRED FROM DIABETIC KETOACIDOSIS. THE DECEASED PATIENTS SISTER STATED THAT THEY WERE UNSURE IF THE PATIENT WAS WEARING AN INSULET PRODUCT. NO FURTHER DETAILS WERE PROVIDED AT THE TIME OF THE CALL. INSULET WILL REPORT THIS CASE TO BE CONSERVATIVE.1
IT WAS REPORTED THAT A PATIENT EXPIRED. THERE WERE NO OTHER DETAILS REPORTED. THREE ATTEMPTS WERE MADE TO OBTAIN MORE INFORMATION.1
IT WAS REPORTED THAT A PATIENT HAS PASSED AWAY FROM NATURAL CAUSES. THE PATIENT WAS WEARING THE OMNI POD AT THE TIME OF DEATH. THE PATIENT HAS BEEN ON DIALYSIS FOR 6 YEARS AND HAS A NUMBER OF OTHER AILMENTS. THE PATIENT HAD HEART PROBLEMS, BLOOD ISSUES AND MOBILITY PROBLEMS. CAUSE OF DEATH WAS NOT DETERMINED.1
IT WAS REPORTED THAT A PATIENT HAS PASSED AWAY ON (B)(6) 2020. THE PATIENT COLLAPSED IN THE FRONT YARD. PATIENT WAS DRIVEN TO THE HOSPITAL, BUT WAS DEAD UPON ARRIVAL. THE PATIENT'S WIFE HAS STATED THAT THEY HAVE NOT BEEN TOLD WHETHER IT WAS A HEART ATTACK OR BLOOD SUGAR LEVEL OF 32 MG/DL THAT HAS KILLED THE PATIENT.1
IT WAS REPORTED THAT A PATIENT HAS PASSED AWAY. THE CAUSE IS UNKNOWN. IT IS ALSO UNKNOWN IF PATIENT WAS WEARING THE DEVICE AT THE TIME OF DEATH. NO ADDITIONAL INFORMATION WAS PROVIDED OR ABLE TO BE OBTAINED.1
IT WAS REPORTED THAT A PATIENT HAS PASSED AWAY. THERE WAS NO OTHER INFORMATION OBTAINED ON THE PATIENT.1
IT WAS REPORTED THAT A PATIENT HAS PASSED AWAY. WE ARE UNABLE TO OBTAIN ANYMORE INFORMATION ON THE EVENT.1
IT WAS REPORTED THAT A PATIENT PASSED AWAY AND THAT SHE WENT TO THE HOSPITAL ABOUT 2 WEEKS PRIOR BECAUSE SHE WAS RETAINING WATER. SHE WAS ADMITTED FOR 5 DAYS BEFORE DISCHARGE. HUSBAND SAID THE HOSPITAL DID NOT PROVIDED TREATMENT. HE TOOK THE PATIENT TO HER DOCTOR THE NEXT DAY, THE DOCTOR CALLED THE AMBULANCE WHO TOOK HER TO ANOTHER HOSPITAL WHERE THEY DRAINED 23 POUNDS OF WATER VIA DIALYSIS OVER 4 DAYS. CUSTOMER WAS DISCHARGED AND WENT HOME FOR 2 DAYS. HUSBAND FOUND HER THE NEXT DAY IN THE BATHROOM AT HOME ON THE FLOOR AND CALLED 911. HE DID NOT KNOW IF SHE WAS WEARING THE POD. PATIENT WAS TAKEN TO THE HOSPITAL TO BE CHECKED BY THE MEDICAL EXAMINER. CALLER SAID IT WAS DETERMINED THAT THE PATIENT DIED OF NATURAL CAUSES BUT COULD NOT GIVE MORE SPECIFIC INFORMATION. PATIENT HAD KIDNEY DISEASE AND FATTY LIVER DISEASE, IN ADDITION TO DIABETES.1
IT WAS REPORTED THAT A PATIENT PASSED AWAY FOR AN UNKNOWN REASON WHILE WEARING THE OMNI POD.1
IT WAS REPORTED THAT A PATIENT PASSED AWAY ON (B)(6) 2020. PATIENT HAD BLOOD GLUCOSE LEVELS OF 583 MG/DL BEFORE THEY WENT TO BED. PATIENT PASSED AWAY IN THEIR SLEEP.1
IT WAS REPORTED THAT ON (B)(6) 2020 A PATIENT PASSED AWAY WHILE WEARING A POD. PATIENT WAS ALSO REPORTED TO HAVE KIDNEY ISSUES. PATIENT WAS TAKING OTHER MEDICATIONS SUCH AS SPIRONOLACTONE, LISINOPRIL, FUROSEMIDE, ATORVASTATIN AND METOPROLOL. NO MORE INFORMATION WAS ABLE TO BE OBTAINED.1
IT WAS REPORTED THAT PATIENT HAD BEEN HOSPITALIZED WITH CONGESTIVE HEART FAILURE (CHF). THE PATIENT WAS TREATED WITH DIALYSIS AND HAD 3 ORGAN FAILURES: LIVER, HEART AND KIDNEYS. PATIENT'S DAUGHTER SAID THAT WHEN HER FATHER WAS ADMITTED INTO THE HOSPITAL HE WAS WEARING THE POD. HE WAS IN THE HOSPITAL FOR ABOUT THREE WEEKS AND HIS BLOOD GLUCOSE WAS AS LOW AS 34 MG/DL AND AS HIGH AS 489 MG/DL. PATIENT STOPPED USING THE OMNIPOD SYSTEM WHILE IN THE HOSPITAL SINCE HE DID NOT HAVE THE MENTAL CAPACITY TO USE IT. PATIENT'S DAUGHTER MENTIONED THAT HE PASSED AWAY AT 8:15 AM ON (B)(6) 2018.1
IT WAS REPORTED THAT PATIENT PASSED AWAY FROM DIABETIC KETOACIDOSIS. IT IS NOT CLEAR WHETHER PATIENT WAS WEARING A POD AT THE TIME OF DEATH AND NO ADDITIONAL INFORMATION WAS PROVIDED.1
IT WAS REPORTED THAT PATIENT PASSED AWAY WHILE WEARING A POD. PATIENT'S CAUSE OF DEATH WAS REPORTEDLY DUE TO DIABETIC KETOACIDOSIS (DKA) AND POSSIBLE COVID-19.1
IT WAS REPORTED THAT THE PATIENT DIED AT THEIR HOME. THE AMBULANCE ARRIVED TO TRY TO REVIVE THE PATIENT, BUT WAS UNSUCCESSFUL. THERE IS NO INFORMATION ON WHAT CAUSED THE DEATH, DUE TO THE AUTOPSY RESULTS NOT RETURNED AT THE TIME OF THE CALL. THE PATIENT WAS REPORTED TO HAVE WOKE UP AT AROUND 3:00 AM AND WAS VOMITING. THE PATIENT ATTEMPTED TO DRINK GATORADE, AFTER TEXTING THEIR ROOMMATE. THE ROOMMATE WENT TO THEIR AID AND FOUND THE PATIENT UNRESPONSIVE ON THE BATHROOM FLOOR. THE PATIENT WAS REPORTED TO HAVE CELIAC DISEASE. NO FURTHER DETAILS.1
IT WAS REPORTED THAT THE PATIENT DIED FROM DIABETES BY THE PATIENT'S GIRLFRIEND. THE PATIENT WAS USING THE OMNIPOD SYSTEM AT THE TIME OF DEATH. THE PATIENT WAS FOUND BY HIS BROTHER 2 DAYS LATER IN THE APARTMENT DECEASED. THE PATIENT WAS TAKEN UNKNOWN MEDICATIONS FOR SEIZURES AND HIGH BLOOD PRESSURE. THE EVENT HAPPENED AROUND (B)(6) 2019. NO FURTHER DETAILS TO REPORT.1
IT WAS REPORTED THAT THE PATIENT EXPIRED DUE TO STAGE 4 PANCREATIC CANCER. THE DATE OF THE EVENT IS UNKNOWN AND WE ARE UNABLE TO CONFIRM IF THE PATIENT WAS WEARING THE DEVICE AT THE TIME OF DEATH. WE WILL ATTEMPT TO CONTACT THE CUSTOMER TO OBTAIN ANY NEW INFORMATION POSSIBLE.1
IT WAS REPORTED THAT THE PATIENT EXPIRED WHILE WEARING THE POD. THE PATIENT'S HUSBAND STATED THAT SHE HAD BEEN SICK AND VOMITED THAT MORNING THREE TIMES, SHE DROPPED A LOT OF WATER WHILE THROWING UP. THE NIGHT PRIOR THE PATIENT WAS OUT AND THE PATIENT HAD TOLD HIM HER WHOLE BODY WAS ACHING AND SHE JUST WANTED TO BE HOME IN HER BED. HE ALSO STATED SHE WAS VERY THIRSTY AND HE HAD GOTTEN HER A WATER, SHE HAD DRANK A QUART OF WATER. HER HUSBAND STATES THAT SHE WAS ALSO RUNNING A FEVER SO HE GAVE HER SOME TYLENOL AND HE CHECKED HER TEMPERATURE AGAIN AND SHE FELT COLD. THEY THINK SHE DIED AT 1 OR 1:30 AM FROM A STROKE. HER HUSBAND HAD GOT UP BEFORE 7 AM TO CHECK ON HER AND SHE HAD BEEN GONE FOR SOME TIME. THE CAUSE OF DEATH WAS UNKNOWN DUE TO NO AUTOPSY BEING PERFORMED.1
IT WAS REPORTED THAT THE PATIENT HAD BEEN HOSPITALIZED WITH DIABETIC KETOACIDOSIS (DKA). THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 1300 MG/DL WHILE WEARING THE POD. PATIENT'S FATHER REPORTED FINDING PATIENT UNCONSCIOUS, AND ATTEMPTED CARDIOPULMONARY RESUSCITATION (CPR) UNTIL PARAMEDICS ARRIVED ABOUT 30 MINUTES LATER; PATIENT WAS TRANSPORTED TO HOSPITAL BY AMBULANCE. AT THE HOSPITAL, PATIENT REMAINED UNCONSCIOUS AND KETONES WERE PRESENT; FATHER REPORTED SHE HAD A FAINT HEARTBEAT AND NO BRAIN FUNCTION DUE TO OXYGEN DEPLETION. ADDITIONALLY, PATIENT WAS FOUND TO HAVE DRUGS IN HER SYSTEM. IT IS UNCLEAR WHEN POD WAS REMOVED, AND HOW PATIENT WAS TREATED AT HOSPITAL. PATIENT WAS EVENTUALLY FLOWN TO ANOTHER HOSPITAL WHERE TESTS AND MONITORING WERE PERFORMED, AND SHE REMAINED ON LIFE SUPPORT. FATHER WAS NOTIFIED ON 10/25, THAT THE PATIENT HAD PASSED AWAY (AT 2:04PM) OF A HEART ATTACK; DEATH OCCURRED 4 TO 5 DAYS AFTER THE MEDICAL EVENT TRANSPIRED.1
IT WAS REPORTED THAT THE PATIENT HAD EXPIRED ON (B)(6) 2019. PATIENT'S SON IN LAW STATED THE CUSTOMER HAD A HEART ATTACK AND WAS TRANSPORTED TO THE HOSPITAL BY AMBULANCE AND PASSED AWAY ABOUT AN HOUR LATER. CUSTOMER HAD LOW BLOOD PRESSURE, KETOACIDOSIS (BECAUSE HIS BLOOD SUGARS WERE VERY HIGH) AND SEPSIS. CUSTOMERS SON IN LAW NOTED THAT A LOT OF THIS WAS BROUGHT ON BY THE HEART ATTACK BECAUSE HIS FATHER IN LAW WAS UNABLE TO MONITOR HIS INSULIN. CUSTOMERS SON IN LAW STATED HE WAS USING HIS SYSTEM AND WEARING A POD DURING THIS TIME. PATIENT WAS NOT PRESCRIBED ANYTHING WHILE IN HOSPICE.1
IT WAS REPORTED THAT THE PATIENT HAD PASSED AWAY AND THAT THEY ARE RETURNING THE OMNIPOD PERSONAL DIABETES MANAGER (PDM) BACK. NO FURTHER INFORMATION PROVIDED.1
IT WAS REPORTED THAT THE PATIENT HAD PASSED AWAY IN HIS SLEEP AND THE OMNIPOD WAS BEING WORN AT THE TIME. THE LAST PATIENT'S BLOOD GLUCOSE (BG) LEVELS READINGS WERE 10 MMOL/L (180 MG/DL) AND THE EXACT CAUSE OF DEATH WAS NOT DETERMINE. NO OTHER INFORMATION WAS PROVIDED ON THIS EVENT.1
IT WAS REPORTED THAT THE PATIENT HAD PASSED AWAY ON (B)(6) 2019 AT 12:01. THERE WAS NO FURTHER INFORMATION PROVIDED.1
IT WAS REPORTED THAT THE PATIENT HAD PASSED AWAY, NO ADDITIONAL INFORMATION WAS PROVIDED.1
IT WAS REPORTED THAT THE PATIENT HAD PASSED AWAY; IT WAS NOT DISCLOSED WHAT HAPPENED. THE WIFE DID STATE THAT THE PATIENT WAS WEARING THE PRODUCT AT THE TIME OF THE EVENT. NO FURTHER INFORMATION WAS PROVIDED OR ABLE TO BE OBTAINED.1
IT WAS REPORTED THAT THE PATIENT HAS PASSED AWAY DUE TO A RECENT URINARY TRACT INFECTION THAT WENT SEPTIC. THE PATIENT'S WIFE WAS CLEAR THAT THE PATIENT'S DEATH WAS NOT RELATED TO THE POD, BUT THE PATIENT WAS WEANING THE POD DURING THE TIME OF DEATH. THE PATIENT'S WIFE REPORTED THAT HE HAD BEEN RECEIVING IRON INFUSIONS FOR ABOUT FOUR YEARS.1
IT WAS REPORTED THAT THE PATIENT PASSED AWAY AT THE HOSPITAL, DUE TO DIABETIC KETOACIDOSIS (DKA) WHILE USING THE OMNIPOD SYSTEM. NO OTHER INFORMATION OR DETAILS WERE PROVIDED ON THIS EVENT.1
IT WAS REPORTED THAT THE PATIENT PASSED AWAY DUE TO MYOCARDIAL INFARCTION (HEART ATTACK). THE PATIENT HAD HIP PAIN OVER THE WEEKEND, AND COULDN'T GET AROUND MUCH. SHE WENT TO SLEEP SUNDAY NIGHT AND THE NEXT MORNING AT 8:30 AM THE PATIENT'S SON FOUND HIS MOTHER PASSED AWAY IN BED. THE PATIENT WAS WEARING THE POD AT THE TIME OF THE EVENT AND WAS NOT HOSPITALIZED.1
IT WAS REPORTED THAT THE PATIENT PASSED AWAY IN HER SLEEP AT HOME ON (B)(6) 2019. PATIENT'S SON STATED SHE FELL WHILE SHE WAS 'IN A REACTION', HITTING HER HEAD THAT HAD CAUSED INTERNAL BLEEDING IN HER BRAIN WHICH SHE THEN PASSED AWAY FROM LATER THAT NIGHT. PATIENT'S SON STATED SHE WAS USING THE OMNIPOD WHEN SHE PASSED AWAY AND THAT SHE FELL DUE TO EXPERIENCING LOW BLOOD GLUCOSE LEVELS. PATIENT'S SON STATED THE PATIENT WAS TAKING TYLENOL AND IBUPROFEN.1
IT WAS REPORTED THAT THE PATIENT PASSED AWAY OF UNKNOWN REASONS. NO FURTHER INFORMATION WAS PROVIDED ON THIS EVENT.1
IT WAS REPORTED THAT THE PATIENT PASSED AWAY ON (B)(6) 2019 DUE TO A CHEST INFECTION AND DIABETIC KETOACIDOSIS (DKA). THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM (ER) IN THE MORNING AND DIED LATER IN THE AFTERNOON, THE OMNIPOD WAS BEING WORN AT THE TIME. NO OTHER INFORMATION WAS PROVIDED ON THIS EVENT.1
IT WAS REPORTED THAT THE PATIENT PASSED AWAY, BUT NO INFORMATION BEYOND THIS WAS GATHERED. FOLLOW-UP ATTEMPTS WERE MADE WITHOUT SUCCESS. NO FURTHER INFORMATION AVAILABLE.1
IT WAS REPORTED THAT THE PATIENT PASSED AWAY, BUT NO OTHER INFORMATION WAS GIVEN TO WHAT EXACTLY OCCURRED. NO FURTHER INFORMATION PROVIDED.1
IT WAS REPORTED THAT THE PATIENT PASSED AWAY. NO OTHER INFORMATION IS AVAILABLE.1
IT WAS REPORTED THAT THE PATIENT PASSED AWAY. THE REPORTER DID NOT PROVIDE ANY FURTHER INFORMATION, HOWEVER THEY STATED THE PATIENT PASSED AWAY, "LAST WEEK" (EXACT DATE WAS NOT PROVIDED). ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION ABOUT THE EVENT, BUT THERE WAS NO ANSWER, SO A VOICE MESSAGE WAS LEFT TO CALL US BACK.1
IT WAS REPORTED THAT THE PATIENT WAS FOUND ON THE COUCH PASSED AWAY. THE MOTHER IN LAW LEFT THE HOUSE AT 9:00 AM AND THE PATIENT WAS ASLEEP AND SNORING ON THE COUCH AND BY 2:00 PM WHEN SHE RETURNED THE SAME DAY HE HAD PASSED. SHE CALLED THE PARAMEDICS AND THEY WERE STILL WORKING ON HIM WHEN WIFE GOT THERE AROUND 2:45 PM. PATIENT WAS REPORTED TO SLIPPED INTO A COMA. NO FURTHER INFORMATION AVAILABLE AS THE AUTOPSY REPORT IS PENDING.1
IT WAS REPORTED THAT THE PATIENT'S BLOOD GLUCOSE LEVELS DROPPED TOO LOW AND THE PATIENT MAY HAVE SLIPPED INTO A DIABETIC COMA. THE PATIENT WENT TO THE HOSPITAL TO BE REVIVED BUT EVENTUALLY PASSED AWAY. THE SISTER DOES NOT KNOW IF THE PATIENT WAS WEARING THE POD AT THE TIME OF DEATH.1
IT WAS REPORTED THAT THERE WAS A PATIENT DEATH ON (B)(6) 2020. PATIENT WAS USING THE POD AT THE TIME OF DEATH. NO OTHER INFORMATION WAS ABLE TO BE OBTAINED.1
THE PATIENT'S DAUGHTER REPORTED THAT HER MOTHER HAD PASSED AWAY AND WILL NEED TO ORDER SOME ECO-BOXES AS THEY STILL HAVE SOME PODS LEFT. THERE WAS NO FURTHER INFORMATION PROVIDED ON THE PATIENT'S DEATH.1
THE PATIENT'S FATHER REPORTED THAT HIS DAUGHTER PASSED AWAY IN HER SLEEP ON (B)(6) 2019. PRIOR TO HIS DAUGHTER'S DEATH SHE WAS HAVING DIARRHEA FOR A COUPLE OF DAYS AND HE SUSPECTS THAT HIS DAUGHTER WAS NOT TAKING HER INSULIN FOR A COUPLE OF DAYS. HE WAS NOT ABLE TO FIND ANYTHING IN THE OMNIPOD PERSONAL DIABETES MANAGER (PDM). HE DOES NOT KNOW THE CAUSE OF DEATH, BUT WHEN ASKED, THE PATIENT'S FATHER SAYS HE SUSPECTS DIABETES INSIPIDUS (DI). THE PATIENT ONLY TOOK MEDICATIONS RELATING TO HER DIABETES.1
THE PATIENT'S WIFE REPORTED THAT HER HUSBAND'S BLOOD GLUCOSE (BG) WAS READING AT 30.5 MMOL/L (550 MG/DL), HE WAS DIZZY AND HAD SHORTNESS OF BREATH SO SHE CALLED HIS GENERAL PRACTITIONER (GP), WHO CAME TO THEIR HOME RIGHT AWAY. THE GENERAL PRACTITIONER INJECTED A MEDICATION (UNKNOWN) UNDERNEATH HIS TONGUE BECAUSE HE ALSO HAD HEART ISSUES. HE WAS THEN TAKEN TO THE HOSPITAL AND UPON ARRIVAL HIS BG ROSE TO 40.9 MMOL/L (737 MG/DL). HE STAYED IN THE HOSPITAL FOR 4 WEEKS DUE TO HIGH BG AND THAT HE HAD A LARGE WOUND ON HIS ANKLE CONTAINING A VIRUS WHICH SPREAD THROUGHOUT THE BLOOD, TAINTED HIS KIDNEYS, HIS BLADDER AND HIS LUNGES. HE ALSO HAS PARKINSON'S DISEASE. HER HUSBAND HAD PASSED AWAY WHILE AT THE HOSPITAL ON (B)(6) 2019 WITH BLOOD GLUCOSE READING BETWEEN 10 AND 13 MMOL/L (180 AND 234 MG/DL).1
THE WIFE REPORTED THAT THE PATIENT HAS PASSED AWAY ON (B)(6) 2019. SHE STATED THAT HE HAD DIED OF A BRAIN BLEED. HE WAS USING THE PRODUCT AT THE TIME. THE PATIENT ALSO HAD LIVER CANCER, KIDNEY CANCER, KIDNEY STONES, AND STROKES. OTHER MEDICATIONS BEING TAKEN INCLUDED ATORVASTATIN, LISINOPRIL, METOPROLOL, PLAVIX, TAMSULOSIN, LEXAPRO AND VERSALAMIN. THE PATIENT WAS HOSPITALIZED AT THE TIME OF DEATH FOR LESS THAN 24 HOURS. NO FURTHER INFORMATION WAS PROVIDED OR ABLE TO BE OBTAINED.1
 
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