FDA issues warning about use of diabetes management devices

Agency reports that unauthorized system resulted in an insulin overdose requiring medical intervention.

The Food and Drug Administration wants providers and patients to be aware of the risks associated with using unauthorized devices for diabetes management—used alone or in tandem with authorized devices.

The FDA on Friday issued a safety communication to providers and diabetic patients who use continuous glucose monitoring systems (CGMs), insulin pumps or automated insulin dosing (AID) systems.

“Millions of Americans use continuous glucose monitors and insulin delivery devices to monitor and treat their diabetes,” says Jeff Shuren, MD, director of the FDA’s Center for Devices and Radiological Health. “Because of the complexity of these devices and the life-saving care they provide, it’s important that patients are aware of the risks that arise when they’re not used as intended or when they use devices not authorized for sale in the U.S."

Also See: FDA approves continuous glucose monitoring system

“The FDA received a report of a serious adverse event in which a patient used an unauthorized device that receives the electronic signal from an FDA authorized glucose sensor and converts it to a glucose value using an unauthorized algorithm,” states the agency’s safety communication.

“Glucose values from this unauthorized continuous glucose monitoring system were sent to an unauthorized automated insulin dosing device to drive insulin dosing,” according to the FDA. “The automated insulin dosing system gave too much insulin in response to repeated incorrect high glucose values sent from the continuous glucose monitoring system. This unauthorized system resulted in an insulin overdose requiring medical intervention.”

While the FDA said that it remains unclear whether the insulin overdose resulted from inaccurate glucose values reported from the unauthorized sensor or a software malfunction in the unauthorized automated insulin dosing system that misinterpreted the electronic signal from the unauthorized continuous glucose monitoring system, the agency emphasized that these devices were not designed to be used together and were combined in a way that had not been thoroughly tested for compatibility.

“When patients combine devices that are not intended for use with other devices or when patients use any unauthorized devices, new risks are introduced that the FDA has not evaluated for safety or effectiveness,” according to the communication. “Patient use of unauthorized diabetes management devices, alone or along with other devices, could result in inaccurate glucose level readings or unsafe insulin dosing. These inaccuracies may lead to injuries requiring medical intervention, such as severe low blood sugar, coma, diabetic ketoacidosis (buildup of acids in blood), and death.”

Further, the agency said it is “aware of manufacturers marketing unauthorized diabetes management devices that use an algorithm to convert raw data from an FDA authorized glucose sensor to a glucose level displayed to the patient” but the FDA “has not evaluated the algorithm that these unauthorized devices use” and that “the algorithm may return inaccurate glucose values.”

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