Medical Device Safety and Recalls: Insulet Corporation, OmniPod Insulin Management System May Fail to Deliver Insulin

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: Medical Device Safety and Recalls: Insulet Corporation, OmniPod Insulin Management System May Fail to Deliver Insulin

A recall has been issued for the Insulet Corporation's OmniPod Insulin Management System. Insulet has identified two issues with these devices.

1. 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.
2. 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). If left untreated, hyperglycemia can cause life-threatening conditions or even death.

The firm has received nine reports in which the device has malfunctioned, including five injuries and no reports of deaths.

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