Food and Drug Administration recalls insulin delivery device | Bart Durham Injury Law

Food and Drug Administration recalls insulin delivery device

As recently as a decade ago, Tennessee had one of the highest incidence rate of diabetes in the country. According to the Tennessee Department of Health, 9.1 percent of adults in the state reported having been diagnosed with diabetes in 2005.

Depending on the type of the illness, a person who has the condition may need to use a device that helps to monitor blood sugar and deliver insulin as needed. These devices can literally save a life. When someone's blood sugar becomes too high or too low, there are serious adverse reactions that can take place. If left untreated, the person can die.

While there are a number of insulin management devices on the market, one that has recently been called into question comes from the Insulet Corporation. The U.S. Food and Drug Administration issued a recall for the OmniPod Insulin Management System in 2015 after the manufacturer reported several problems.

The first issue is that if the device fails to deliver insulin to the patient, it signals an alarm. Following the alarm, no insulin can be delivered. The other issue is that the tube that is supposed to deliver insulin will either retract after insertion or fail to insert completely into the patient. In both situations, the FDA reports that the device will not give a patient an accurate dosage of insulin. Unfortunately, there have already been nine reports of malfunction that resulted in five injuries.

The FDA notes that any manufacturer or importers are required to report such failures to the administration, especially if any defect results in a serious injury or death. Further, consumers are encouraged to report faulty devices through the administration’s Safety Information and Adverse Event Reporting Program. 

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