FDA Issues Warning on Abbott Glucose Monitor Sensors Following Deaths

The U.S. Food and Drug Administration (FDA) has issued a warning regarding certain glucose monitor sensors produced by Abbott Diabetes Care. This alert follows reports linking the devices to seven deaths and over 700 injuries globally. The affected products, specifically the FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors, may provide inaccurate low glucose readings.

Safety Risks Associated with Inaccurate Readings

Inaccurate glucose readings can lead to dangerous treatment decisions for individuals with diabetes. Patients may consume excessive carbohydrates or mistakenly adjust their insulin doses, potentially resulting in severe health risks, including injury or death. The FDA emphasized the urgency of this matter in their recent announcement.

• Devices are designed to measure glucose levels in fluid below the skin.
• Information is transmitted wirelessly to devices or smartphones.

Scope of the Recall

The recall affects approximately three million sensors distributed across the U.S. from a specific production line. Abbott reported that about half of these sensors have expired or already been used. As of November 14, the company confirmed seven deaths worldwide, with 736 serious adverse events. Notably, there were no reported deaths in the U.S., although 57 injury cases were documented.

Identifying Affected Devices

Consumers should be aware of the specific model numbers of the potentially dangerous sensors:

Consumers are advised to discontinue the use of these sensors and discard them immediately. Abbott has reached out to all customers regarding this issue and has also resolved the production problem associated with the affected lot.

Next Steps for Consumers

Individuals using affected sensors can visit FreeStyleCheck.com for guidance on checking their devices and to request replacements. The FDA reassured users that other FreeStyle Libre products remain unaffected by this warning.