Following dozens of reports involving problems with OmniPod Insulin management systems, warnings have been issued about a risk that the needles may fail to deploy and deliver life-saving insulin.
The FDA and Insult Corp. issued an OmniPod Insulin Management System warning on December 1, indicating that at least 66 Medical Device Reports have been received that suggest the needle mechanism failed to deploy the injectable needle to deliver insulin treatments to consumers.
To date, at least three individuals required medical attention due to delayed insulin treatments, but no serious injuries or deaths have been reported.
The OmniPod Insulin Management Systems are designed to provide individuals with diabetes a way to manage their blood glucose levels by using the portable injectors to delivery insulin treatments when needed. The systems have a mechanism that allows a needle to deploy into the designated area to deliver insulin treatments. However, the interruption of insulin delivery may cause elevated blood glucose that if left untreated could result in diabetic ketoacidosis and further injuries. Three of the Medical Device Reports have resulted in users who were delayed treatment to seek medical attention.
The Field Safety Notification warns that the problem may affect 15 lots of OmniPod Insulin Management Systems sold in the United States with catalog number POD-ZXP420 and lot numbers L41880, L41881, L41892, L41895, L41897, L41898, L41899, L41900, L41901, L41902, L41903, L41904, L41905, L41906, and L41907. Three lots of the management system were sold internationally with catalog number 14810 and lot codes L41908, L41910, and L41935.
Insulet claims to have corrected the manufacturing process and implemented additional inspection steps to prevent further needle mechanism problems.
Customers with Pods from the affected lots are being asked to ensure the needle mechanism is deploying properly and may contact Insulet’s Customer Care at 1-855-407-3729 for further questions or concerns. Consumers are also being asked to report any adverse events or side effects related to the use of the Pods to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program at www.fda.gov/MedWatch/report.