Insulet Issues Medical Device Correction Regarding its Omnipod DASH™ Insulin Management System
Consumer safety is Insulet’s top priority and this action is taken voluntarily with the knowledge of the
As part of our ongoing quality monitoring processes, we have identified that on rare occasions, the Omnipod DASH PDM may suggest an inaccurate bolus amount based on a blood glucose value that is more than 10 minutes old when the user does not exit the bolus calculator as designed or when a system alarm interrupts a bolus calculation. If the user delivers the bolus, this may result in over or under delivery of insulin which may lead to hypoglycemia or hyperglycemia. No injuries have been reported as a result of this potential issue and the Omnipod DASH System is safe for continued use and distribution.
This notice does not affect the Omnipod DASH Pods or the widely distributed Omnipod Insulin Management System. All affected Omnipod DASH users are being notified by email and local mail and replacement devices will be made available starting in March to all Omnipod DASH users. Additional information can be found on our website www.omnipod.com.
For further questions regarding the information provided in this Medical Device Correction, consumers are requested to contact Insulet’s 24/7 Customer Care in any of the following markets:
Deborah R. Gordon
Vice President, Investor Relations