FDA Issues Warning About Unauthorized Diabetes Devices

By Amy Orciari Herman

Edited by Susan Sadoughi, MD, and André Sofair, MD, MPH

Patients could be using diabetes management devices that haven't been authorized for sale in the U.S., the FDA warned clinicians on Friday. These include some insulin pumps, continuous glucose monitors, and automated insulin dosing systems.

Patients may be using unauthorized devices alone or may be combining devices that aren't meant to be used together, which could lead to incorrect glucose measurements and unsafe insulin dosing.

The warning was spurred by the following reported case: A patient required medical intervention for an insulin overdose after an unauthorized continuous glucose monitoring system (that included an FDA-authorized glucose sensor and an unauthorized algorithm) potentially sent incorrectly high glucose measurements to an unauthorized automated insulin dosing system.

The FDA urges clinicians to report adverse events associated with such devices to its MedWatch program (see link below).