Note from Insulet:
Dear Valued Insulet Customer,
Insulet Corporation, the manufacturer of the OmniPod Insulin Delivery System, is committed to keeping you and your healthcare professionals up-to-date in the event there are any issues that arise related to our products.
As part of our product quality monitoring process, we have identified that 15 lots of OmniPod which were distributed in the U.S. had a slight increase in the reported cases in which the Pod’s needle mechanism failed to deploy or there was a delay in the deployment of the needle mechanism. The reported incidence of this product issue in the affected lots is approximately 1%-2%. Once we recognized this, we corrected the manufacturing process and implemented additional inspection steps.
No serious injuries or deaths have been reported in patients using OmniPod devices from the affected lots.
Download this .pdf to read the rest of this notice, and see if you might be affected:Patient Communication (FINAL).pdf (129.5 KB)