OmniPod Insulin Management System by Insulet: Field Safety Notification

Reported Cases of Needle Mechanism Deployment Failure or Delay

[Posted 12/02/2015]

OmniPod Insulin Management SystemISSUE

On November 2, 2015, Insulet Corporation 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. 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. 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).

The affected Pod lots have resulted in 66 Medical Device Reports, of which three required medical intervention. See the Press Release for a listing of affected product lots.

BACKGROUND

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).

What Is OmniPod?

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

RECOMMENDATION

Insulet has notified its distributors and customers by email, FedEx, and phone calls. 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.

  • Read from FDA at http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm475156.htm

Last Updated: 2015-12-02

Field Safety Notification for Insulin Management System by Insulet