Insulet Recalls Insulin Management Systems Due to High Failure Rate

Insulet Recalls Insulin Management Systems Due to High Failure Rate
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August 28, 2015

An insulin management company is recalling a signature product.

Insulet Corporation announced the decision earlier this summer to recall its OmniPod Insulin Management System. The voluntary recall applies to over 40,000 boxes of the product. This action is being taken as there is a possibility that some of the Pods from the affected lots have a higher rate of failure than Insulet's current manufacturing standards.

There are two ways in which these Pods can fail at a rate that is higher than Insulet's current standard. The cannula may either completely retract or fail to fully deploy, which may result in the patient not receiving the expected insulin dose. Additionally, the Pod may trigger an audible alarm indicating it will no longer deliver insulin and will need to be replaced. Both situations can result in the interruption of insulin delivery that can cause hyperglycemia, which can result in diabetic ketoacidosis (DKA).

The affected Pod lots have resulted in 90 Medical Device Reports of which 13 required medical intervention. No serious injuries or deaths have been reported in patients using OmniPod devices from the affected lots.

For a list of the affected lots, see the U.S. Food and Drug Administration (FDA) press release.

Insulet has notified its distributors and customers and is arranging for return and replacement of all recalled product. Consumers with questions may contact the company at (855) 407-3729.