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The U.S. Food and Drug Administration (FDA) is aware that Insulent has notified all affected customers to discontinue the use of certain Omnipod 5 Pods and for the devices to be removed from where they are used or sold. Insulent has reported certain lots of Pods may have a small tear in the internal tubing that delivers insulin. This tear may leak insulin inside the Pod; if insulin is not properly delivered, 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 and can be life-threatening if not treated.
If there is a fluid leak inside the Pod, the device may trigger a hazard alarm. If a hazard alarm occurs, users should remove their Pod and replace it immediately to restore insulin delivery. The risk of under-delivery increases if a user applies more than one Pod from an affected lot consecutively.
As of March 12, Insulet has reported 18 serious injuries and no deaths associated with this issue.
CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.
Questions?
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Insulet at 1-800-641-2049 or visit https://www.omnipod.com/current-podders to reach a live chat agent.
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