Omnipod® Insulin Management System - Omnipod®

Companies: Insulet Corporation, 100 Nagog Park, Acton, Massachusetts, United States, 01720.

The defect is related to tears on the external (exposed) soft cannula. The defect is consistently located near the bottom housing window, with similar physical appearance and tear orientation across devices. The cannula tear may result in a compromised fluid path due to damage to the cannula, leading to potential reduced or interrupted insulin delivery. If insulin is not delivered properly, user may experience high blood glucose levels due to under-delivery of insulin. In the most severe cases, prolonged and persistent high blood glucose levels can lead to diabetic ketoacidosis (DKA), a serious medical condition that requires prompt medical treatment and can be life-threatening if not treated. To identify the impacted product and lot number, users will be asked to review the notification letter and follow the instructions: Discontinue use of any impacted pod immediately. If the pod the user is currently using, is from an affected lot, it is important that the user immediately changes the pod to resume insulin delivery. When changing the pod, confirm that the new pod is not from an affected lot.