UPDATED 09/10/2015. Recall Classified as Class I. FDA Class I Recall notice issued.[Posted 08/28/2015]
AUDIENCE: Risk Manager, Patient, Internal Medicine
ISSUE: Insulet Corporation initiated a lot-specific voluntary recall of 40,846 boxes (10 Pods per box) of the OmniPod (Pod) Insulin Management System. This field corrective action is due to the possibility that some of the Pods from these lots may have a higher rate of failure than Insulet’s current manufacturing standards. This recall does not affect the OmniPod Personal Diabetes Manager (PDM).
There are two ways in which these Pods can fail at a rate that is higher than Insulet’s current standard. The cannula may either completely retract or fail to fully deploy, which may result in the patient not receiving the expected insulin dose. Or the Pod may trigger an audible alarm indicating it will no longer deliver insulin and will need to be replaced. Both situations can result in the interruption of insulin delivery that can cause hyperglycemia, which, if left untreated, can result in diabetic ketoacidosis (DKA).
OmniPods from the affected lots were distributed to customers from December 2013 to March 2015. See thePress Release for a listing of affected lots.
BACKGROUND: The affected Pod lots have resulted in 90 Medical Device Reports of which 13 required medical intervention. No serious injuries or deaths have been reported in patients using OmniPod devices from the affected lots.
RECOMMENDATION: Insulet has notified its distributors and customers by email, FedEx, and phone calls and is arranging for return and replacement of all recalled product. Consumers with questions may contact the Company via telephone at 1-855-407-3729 at any time.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178