An estimated 7 million Omnipod insulin pods may have had a manufacturing error that resulted in underdelivery of the drug, the manufacturer said in an alert.
WASHINGTON — An estimated 7 million Omnipod insulin pods are regulated. Voluntary medical device correction The pods may not deliver enough insulin due to manufacturing errors.
this alarmOn May 26, Insulet Corporation, Inc. and the FDA released reports of 24 “serious adverse events,” including hospitalizations due to hyperglycemia due to insufficient delivery. No deaths have been reported.
The correction said a manufacturing error caused a small tear in the tube between the skin and the capsule, which could cause insulin to leak instead of being delivered into the body, potentially resulting in insufficient drug delivery.
Omnipod 5, Omnipod DASH, and Omnipod Insulin Management System (Omnipod Eros) Pods are affected by a corrective alert. This alert is not limited to the United States, as these products are distributed globally. This correction does not affect continuous glucose monitoring systems or CGM readings.
The pods have been shipped to at least 22 countries, according to the agency product website.
Insulet said an estimated 60% of the affected pods have expired or been used. The adjustment will affect approximately 8.5% of the company’s global production from 2025 onwards.
Users may smell insulin or notice moisture or adhesive on their skin after the Pod dispenses product. The alert says users may not notice the issue because it can be difficult to detect.
Insulet is contacting users of these products to help them identify problematic pods. Anyone who owns the above pods should stop using them and get a working pod replaced free of charge.
Each country has a different product and lot code and where to find it. Search for your Pod batch code here.
