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Class I Recall Issued for OmniPod Insulin Management System

Sep 14, 2015

The OminPod Insulin Management System manufactured by Insulet Corporation has been recalled because it may fail to deliver insulin, an announcement by the U.S. Food and Drug Administration (FDA) states. The device is an insulin pump used to deliver insulin in people with diabetes. The "Pod" component is a small adhesive pump that sticks directly on the body; a tube is inserted into the skin to administer the insulin.

The recall was designated as Class I, which is the FDA's most serious recall status. Class I recalls are reserved for devices that present a reasonable risk of serious injury or death. In this case, there were two defects that could result in failure to deliver insulin. One problem is that the tube either does not fully insert into the skin or completely retracts after it is inserted. There is no alarm to notify users that the tube has failed to connect, and the Pod will continue to pump insulin without success. The other issue that the Pod will not pump insulin after providing an audible alarm displaying a failure. The FDA notification states that "Both failures can result in inaccurate dosage of insulin which can lead to high blood sugar (hyperglycemia). If left untreated, hyperglycemia can cause life-threatening conditions or even death."

The defect has been linked to nine reports of malfunctions, including five injuries. No deaths have been reported thus far. Insulet informed customers of the recall on July 13th. Customers are instructed to set affected Pods aside, and arrange for a replacement. The device was manufactured and distributed from December 2013 to March 2015. In the United States, 40,846 boxes (each box containing 10 pods) were recalled.

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