The FDA Warns Against Use of Devices for Diabetes Management Not Authorized for Sale in the U.S.

The U.S. Food and Drug Administration (FDA) is warning of risks associated with use of unauthorized devices for diabetes management used alone or along with other devices.

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, such as severe low blood sugar, coma, diabetic ketoacidosis (buildup of acids in blood), and death. The FDA received a report of a serious adverse event in which a patient using an unauthorized diabetes management device experienced an insulin overdose requiring medical intervention. In addition, the FDA 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 user, which may return inaccurate glucose values. The FDA recommends that people with diabetes: Talk to their health care provider about diabetes management devices and how to use them correctly. Use diabetes management devices that the FDA authorized for sale in the U.S. and use them according to manufacturer instructions. You may ask the manufacturer or you may contact the FDA, at DICE@FDA.HHS.GOV, 800-638-2041 or 301-796-7100, if you have questions about the FDA regulatory status of any particular product. Be aware that the FDA has not evaluated the safety and effectiveness of unauthorized diabetes management devices or of systems that combine devices in unintended ways, which may introduce unknown risks. Report adverse events to the FDA through MedWatch.

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