7 deaths, hundreds of injuries may be linked to diabetes glucose monitor errors, FDA says

Patients are being urged to discontinue the use of certain glucose monitors manufactured by Abbott Diabetes Care following the discovery of malfunctioning sensors that may be linked to numerous adverse events and even fatalities, according to a statement released by the Food and Drug Administration (FDA) on Tuesday.

Abbott Diabetes Care conducted internal testing which revealed that certain sensors in the FreeStyle Libre 3 and FreeStyle Libre 3 Plus devices may provide inaccurate low glucose readings, as mentioned in a news release by the company. Abbott reported a total of 736 adverse events potentially associated with the issue, with 57 of them occurring in the United States. Additionally, seven deaths, none of which were in the U.S., were potentially linked to the sensor malfunction. The FDA classified this error as a “potentially high-risk issue” in a news release.

Individuals with diabetes rely on accurate glucose readings to effectively manage their condition. Incorrect low readings can lead to the consumption of excessive carbohydrates or the omission or delay of insulin doses, which may result in serious health risks, including injury or death, as emphasized by Abbott.

The sensor malfunction was isolated to a specific production line responsible for manufacturing the Libre 3 and Libre 3 Plus sensors. Approximately three million devices are affected, with an estimated half having expired or been utilized.

Patients who are currently using a Libre 3 or Libre 3 Plus sensor are advised to check the model number and unique device identifiers to determine if their device is one of the affected ones, as recommended by both the FDA and Abbott. The model numbers for the impacted FreeStyle Libre 3 sensors are 72081-01 and 72080-01, while the unique device identifiers are 00357599818005 and 00357599819002. For the affected FreeStyle Libre 3 Plus sensors, the model numbers are 78768-01 and 78769-01, and the unique device identifiers are 00357599844011 and 00357599843014. The full list of affected lots can be found on the FDA’s website.

Individuals with affected devices should cease using them immediately, according to Abbott and the FDA. Replacement devices can be requested free of charge on www.FreeStyleCheck.com. Patients are advised to rely on a blood glucose meter or the built-in meter on a FreeStyle Libre 3 Reader for treatment decisions when sensor readings do not align with their symptoms or expectations.

Abbott and the FDA have confirmed that FreeStyle Libre 3 readers and mobile apps have not been impacted by the sensor issue, and no other Libre-brand sensors are affected. The cause of the sensor malfunction has been identified and resolved by Abbott, with no disruptions to the supply expected.

In conclusion, it is crucial for individuals using glucose monitors to stay informed about any potential issues with their devices and take necessary precautions to ensure their health and safety. Regular monitoring and prompt action in response to sensor inaccuracies are essential for effective diabetes management.