A problem has been found in certain lots of OmniPod distributed in the U.S. and internationally. This failure may cause elevated blood glucose (hyperglycemia) which, if left untreated, can result in diabetic ketoacidosis (DKA).
Insulet Corporation initiated a lot-specific voluntary Field Safety Notification for 15 lots of the OmniPod (Pod) which were distributed in the U.S. and three lots which were distributed internationally for use by people living with diabetes.
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.
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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
Source: FDA
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