Omnipod 5 — the world’s first available tubeless, wearable, automated insulin delivery system — is a patch-based pump system designed to proactively correct for glucose highs every five minutes and protect against lows with insulin dosing.
Acton, Massachusetts-based Insulet said it identified a manufacturing issue with certain Omnipod 5 lots through its ongoing product monitoring. Its correction applies to specific identified lots distributed in the U.S. All other Omnipod 5 pods and Omnipod products remain safe to use.
Insulet said that certain pods from specific lots may have a small tear in the internal tubing that delivers insulin. If this occurs, insulin may leak inside the pod rather than infuse into the body as intended. When the pod fails to deliver insulin properly, users may experience high blood glucose levels due to under-delivery.
In severe cases, prolonged and persistent high blood glucose levels can lead to diabetic ketoacidosis (DKA).
According to a news release, Insulet received 18 reports of serious adverse events associated with high blood glucose levels. Those events included hospitalization and DKA. The company reports no deaths related to the issue. It noted that the issue does not affect the continuous glucose monitor (CGM) systems that integrate with Omnipod 5.
Actions taken by Insulet after identifying this issue
Following its investigation, Insulet said it implemented updates to its manufacturing processes and quality controls. These updates aim to strengthen detection and prevention and further support the integrity of its products.
Pods involved in the correction represent approximately 1.5% of annual Omnipod 5 pod production globally.
Insulet continues to manufacture and ship the unaffected systems and does not anticipate disruptions to customer shipments, product availability or new patient starts. The company notified the FDA of its action as well.
“Patient safety and product quality remain Insulet’s highest priorities,” the company said.
Insulet said that customers should visit omnipod.com/check-pods to confirm whether the correction includes their pod lot number. They can request replacement pods at no cost. If users identify that a pod from an affected lot is in current use, customers should discontinue use and replace it with a pod from an unaffected lot.
