Several lots of the OmniPod Insulin Management System were affected by a recent field safety notification about needle mechanisms failing to deploy or demonstrating a delay in deployment, a Dec. 1 FDA press release announced.
Insulet Corporation issued the notification because the failures or delays have resulted in 66 medical device reports, including 3 that required medical intervention. The reported incidence of this issue in the affected lots is about 1% to 2%. If deployment of the needle mechanism fails, the needle is not inserted, preventing insulin delivery. The company has corrected the manufacturing process and has implemented additional inspection steps. The FDA recommends that consumers using products from the affected lots ensure that the needle mechanism deploys properly.