OmniPod Insulin Pump Recalled Because It May Fail to Deliver Proper Insulin Dose

In July, Insulet Corporation of Billerica, Massachusetts, recalled nearly 41,000 insulin pump “Pods” that may not deliver the proper insulin dose to the user.

The OmniPod Insulin Management System is an insulin pump used to deliver insulin to people with diabetes. The insulin pump “Pod” is a small adhesive pump that sticks directly to the body. Insulin is delivered through a small port holding a tube that is inserted into the skin.

Insulet initiated the recall after identifying two issues with these devices:

  • The tube either fails to fully insert into the skin or completely retracts after insertion. This failure occurs without an alarm and the Pod will continue to pump insulin.
  • The Pod will provide an audible alarm signal and display a failure. Once the alarm occurs, the Pod will not pump insulin.

Both failures can result in inaccurate dosage of insulin, which can lead to high blood sugar (hyperglycemia). Hyperglycemia can cause life-threatening conditions or even death. Insulet said it has received nine reports in which the device had malfunctioned, including five injuries, but no reports of deaths.

The FDA has classified this a Class 1 recall, its most serious recall category. In a Class 1 recall, there is a reasonable probability that use of the product will cause serious adverse health consequences or death.

The affected lot numbers can be found in the recall announcement on the FDA web site. The recalled devices were manufactured from December 2013 to March 2015 and were distributed from December 2013 to March 2015. In the U.S., 40,846 boxes were recalled, (10 pods per box).

Insulet notified customers of the recall on July 13, 2015 via email or Federal Express. Customers that did not respond to the email or Federal Express received follow-up phone calls. Customers with questions can contact Insulet Customer Care at 1-855-407-3729, 24 hours a day, 7 days a week.

Insulet said customers who have Pods from the affected lots should set them aside and Insulet will replace them at no charge. Customers can arrange for return and replacement from Insulet by completing the form online (https://www.myomnipod.com/podinfo); by returning a reply card; or by calling Insulet Customer Care at 1-855-407-3729 (any time day or night).

The FDA encourages health care professionals and patients to report adverse reactions or quality problems to MedWatch: The FDA Safety Information and Adverse Event Reporting Program online, by regular mail or by fax.

 

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