FDA Warns About Unauthorized Diabetes Devices

The US Food and Drug Administration (FDA) recently warned the public about possible health risks tied to using unapproved devices for diabetes management.

Devices like automated insulin dosing systems, insulin pumps, and continuous glucose monitors that the FDA hasn't approved could lead to unsafe insulin dosing and inaccurate blood sugar readings, according to a recent FDA safety communication.

"By using products that have not been reviewed by the agency for safety and effectiveness, patients with diabetes may be putting themselves at risk for serious injury or even death,” said Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, in a press release. “Today’s warning is part of our ongoing public health commitment to protect patients and communicate with the public when we become aware of issues stemming from the use, or misuse, of medical devices.”

The FDA noted that it is aware of companies that are illegally marketing unapproved diabetes management devices. The agency also noted that it knows that some patients combine parts or devices in ways that have not been tested and may be unsafe.

Using diabetes management devices that haven't been tested for safety and approved by the FDA can lead to inaccurate blood sugar measurements and improper insulin dosing. Being unable to accurately monitor blood sugar or receiving too much or too little insulin can lead to serious diabetes complications that can require hospitalization. These issues can even become deadly.

Similarly, using these devices improperly can cause life-threatening health problems in some cases.

That's why the FDA recommended that patients speak with their health care providers about their diabetes management options before starting or stopping the use of any device or treatment method.

The FDA also noted that it was monitoring for reports of adverse health events tied to the use of unapproved diabetes management devices. If you have experienced an adverse event tied to such a device, you can report it to your health care provider and the FDA's MedWatch program.