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Safety

Company Announcement

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

Insulet Corporation Issues Field Safety Notification of OmniPod Insulin Management System

For Immediate Release

December 1, 2015

Contact

Consumers

Insulet Customer Care
1-855-407-3729

Announcement

On November 2, 2015, Insulet Corporation (Insulet or the Company) initiated a lot-specific voluntary Field Safety Notification (Notification) for 15 lots of the OmniPod (Pod) which were distributed in the U.S. and three lots which were distributed internationally.

Insulet has notified its distributors and customers by email, FedEx, and phone calls beginning on November 2, 2015, as well as all applicable regulatory agencies, including U.S. Food and Drug Administration (FDA). Consumers with questions may contact Insulet Customer Care via telephone at 1-855-407-3729 at any time.

This Notification is due to a slight increase in the reported cases in which the Pod’s needle mechanism failed to deploy or there was a delay in the deployment of the needle mechanism. The reported incidence of this product issue in the affected lots is approximately 1%-2%. Once this issue was recognized, the Company corrected the manufacturing process and implemented additional inspection steps.

This Notification does not affect the OmniPod Personal Diabetes Manager (PDM).

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.

Consumers who have Pods from the affected lots should ensure the needle mechanism has deployed properly, and may contact Insulet Customer Care via telephone at 1-855-407-3729 at any time.

OmniPods from the affected lots listed below were distributed to customers in September 2015:

Distribution Catalog Number Description Lot Number
United States POD-ZXP420 OmniPod®, Insulin Management System L41880
L41881
L41892
L41895
L41897
L41898
L41899
L41900
L41901
L41902
L41903
L41904
L41905
L41906
L41907
International 14810 OmniPod®, Insulin Management System L41908
L41910
F41935
 

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

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Page Last Updated: 12/02/2015
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