Insulet Begins Voluntary Medical Device Correction for Certain Omnipod 5 Pods in the U.S.

Insulet Corporation has initiated a voluntary Medical Device Correction for specific lots of Omnipod 5 Pods due to a “manufacturing issue” discovered through ongoing product monitoring. This action applies only to specific identified lots distributed in the United States; and all other Omnipod 5 Pods and Omnipod products remain safe to use, according to the company.

The manufacturing issue that prompted the correction involves certain Pods from specific lots that may have a small tear in the internal tubing that delivers insulin. If the tear occurs, insulin can leak inside the Pod instead of being fully delivered into the body as intended.

If insulin is not delivered properly, users 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.

Insulet has received 18 reports of serious adverse events associated with high blood glucose levels, including hospitalization and DKA. No deaths have been reported, however. The U.S. Food and Drug Administration (FDA) has been notified of this action.

This issue does not affect continuous glucose monitoring (CGM) systems or CGM readings.

Following its investigation, Insulet has implemented updates to its manufacturing processes and quality controls to strengthen detection and prevention and further support product integrity. The Pods involved in this correction represent approximately 1.5% of annual Omnipod 5 pod production globally, Insulet bigwigs noted.

Insulet continues to manufacture and ship Omnipod 5 Pods and does not expect the Correction to disrupt customer shipments, product availability, or new patient starts.

Customers should visit omnipod.com/check-pods to confirm whether their Pod lot number is included in this voluntary Medical Device Correction and request replacement Pods at no cost. If a Pod from an affected lot is currently in use, customers should discontinue use and replace it with a Pod from an unaffected lot.

Customers with questions or needing assistance may contact Insulet Product Support at 800-641-2049 (available 24/7) or use the live agent chat at omnipod.com/current-podders.

Headquartered in Massachusetts, Insulet Corporation is a medical device company simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides an alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet’s flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections or fingersticks, and can be controlled by a compatible personal U.S. smartphone or by the Omnipod 5 Controller. Insulet also leverages the design of its Pod by tailoring its Omnipod technology platform for delivering non-insulin subcutaneous drugs across other therapeutic areas.