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.
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.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm.
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-332-0178.