Insulet Corp (Omnipod)

March 2022
Device ProblemTotal
Activation, Positioning or SeparationProblem20
Activation, Positioning or SeparationProblem; Material Twisted/Bent3
Adverse Event Without Identified Device or Use Problem7
Difficult or Delayed Activation3
Difficult to Insert29
Difficult to Insert; Material Twisted/Bent6
Failure to Charge1
Failure to Fire61
Failure to Power Up1
Fluid Leak5
Fluid Leak; Activation, Positioning or SeparationProblem; Material Twisted/Bent1
Fluid Leak; Difficult to Insert; Material Twisted/Bent1
Fluid Leak; Failure to Fire1
Fluid Leak; Material Twisted/Bent15
Fluid Leak; Material Twisted/Bent; Unintended Movement1
Fluid Leak; Unintended Movement6
Insufficient Information49
Loss of or Failure to Bond; Fluid Leak; Unintended Movement3
Loss of or Failure to Bond; Material Twisted/Bent5
Loss of or Failure to Bond; Material Twisted/Bent; Unintended Movement3
Loss of or Failure to Bond; Unintended Movement91
Material Twisted/Bent101
Material Twisted/Bent; Unintended Movement5
Premature Activation53
Retraction Problem6
Unintended Movement23