Faulty Insulin Delivery in OmniPods Prompts Recall from Insulet

Faulty Insulin Delivery in OmniPods Prompts Recall from Insulet
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December 2, 2015

Insulet Corporation has initiated a Field Safety Notification for 18 lots of its OmniPod product due to potentially defective needles.

This Notification is due to a slight increase in the reported cases in which the Pod's needle mechanism delayed or failed to deploy. The reported incidence of this product issue in the affected lots is approximately 1 to 2 percent.

In the event a needle mechanism fails to deploy, the needle will not be inserted and insulin delivery will not begin. The interruption of insulin delivery may cause elevated blood glucose (hyperglycemia), which, if left untreated, can result in diabetic ketoacidosis (DKA).

If a patient has activated a Pod and experiences unexpected elevated blood glucose levels, a healthcare professional should be consulted.

The affected Pod lots have resulted in 66 Medical Device Reports, of which three required medical intervention. No serious injuries or deaths have been reported in patients using OmniPod devices from the affected lots.

Insulet notified its distributors and customers by email, FedEx, and phone calls beginning on November 2, 2015. Consumers who have Pods from the affected lots should ensure the needle mechanism has deployed properly.

Patients with questions can contact Insulet Customer Care via telephone at (855) 407-3729.