Insulet Corporation announced on Mar. 13 a voluntary medical device correction for specific lots of its Omnipod 5 Pods distributed in the United States after identifying a manufacturing issue during product monitoring.
The company said that only certain identified lots are affected, and all other Omnipod 5 Pods and Omnipod products remain safe to use. The correction was initiated after Insulet found that some pods may have a small tear in the internal tubing responsible for delivering insulin, which could result in insulin leaking inside the pod rather than being infused into the body as intended.
Improper insulin delivery can cause high blood glucose levels, and in severe cases, may lead to diabetic ketoacidosis (DKA), a serious condition requiring prompt medical attention. Insulet reported receiving 18 reports of serious adverse events related to high blood glucose levels, including hospitalizations and DKA, but no deaths have been reported. The company clarified that this issue does not affect continuous glucose monitoring systems or their readings.
Following an investigation, Insulet has updated its manufacturing processes and quality controls to improve detection and prevention measures. The affected pods represent about 1.5% of annual global production of Omnipod 5 pods. Insulet stated it continues to manufacture and ship Omnipod 5 Pods without anticipated disruption to customer shipments or new patient starts.
The U.S. Food and Drug Administration has been notified of this action. Customers are advised to visit omnipod.com/check-pods to determine if their pod lot number is included in the correction and request free replacements if necessary. Users currently using an affected pod should discontinue use immediately and switch to an unaffected lot.
Insulet emphasized that patient safety and product quality remain its highest priorities as it addresses this issue.
