Company: Insulet Corporation
Date of Enforcement Report: 9/10/2015
Class l:

PRODUCT

The OmnniPod 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 on the body. Insulin is delivered through a small port holding a tube that is inserted into the skin.

REASON
Insulet has identified 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). 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.

RECALLING FIRM/MANUFACTURER
Insulet Corporationon, Billerica, MA 7/13/2015.Voluntary: Firm Initiated recall is ongoing.

FDA District: Los Angeles

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