Manufacturer Recalls OmniPod Insulin Pump Because Device May Fail to Deliver Proper Insulin Dose

Because of malfunctions that may result in the device not delivering the proper dose of insulin, Insulet Corporation of Billerica, Massachusetts, has recalled 40,846 boxes of its insulin pump “Pods.”

The OmniPod Insulin Management System is an insulin pump used to deliver insulin without injections to people with diabetes. The 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 recalled the devices after receiving reports of two types of malfunctions affecting the Pods:

• The tube either fails to fully insert into the skin or completely retracts after insertion. No alarm sounds and the Pod will continue to pump insulin.
• The Pod will provide an audible alarm signal and display a failure. Once the alarm sounds, the Pod will not pump insulin.

Either of these issues can result in the patient not receiving an accurate dosage of insulin, and this 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 malfunctioned in one of these ways. The reports included five injuries, though to date, there are no reports of deaths due to these malfunctions.

In the recall announcement, the Food and Drug Administration (FDA) explains that this is a Class 1 recall, the FDA’s most serious recall category. A Class 1 recall is reserved for situations where there is a reasonable probability that use of the device will cause serious adverse health consequences or death.

The recall announcement on the FDA web site has a list of affected lot numbers of the recalled OmniPods. The recalled Pods were manufactured from December 2013 to March 2015 and were distributed nationwide during that period. Insulet has recalled 40,846 boxes; each box contains 10 pods.

On July 13, 2015, Insulet began notifying customers via email or Federal Express. Customers who did not respond to these notifications received follow-up phone calls. Customers who have questions about the OmniPod recall can reach 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 immediately set them aside. Insulet will replace the Pods at no charge. Customers can arrange for return and replacement from Insulet on one of three ways: 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 with the Insulet OmniPod to MedWatch: The FDA Safety Information and Adverse Event Reporting Program online, by regular mail, or by fax.

 

from Parker Waichman http://www.yourlawyer.com/blog/manufacturer-recalls-omnipod-insulin-pump-because-device-may-fail-to-deliver-proper-insulin-dose/