FDA Issues Warning on Abbott Glucose Monitors Linked to Deaths
The U.S. Food and Drug Administration (FDA) has issued a warning regarding certain glucose monitor sensors manufactured by Abbott Diabetes Care, following reports linking the devices to seven deaths and over 700 injuries worldwide. The alert specifically concerns the FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors, which may deliver inaccurate low glucose readings that could lead to dangerous health decisions for individuals with diabetes.
According to the FDA, the incorrect readings from these sensors could mislead users into consuming excessive carbohydrates or delaying necessary insulin doses. “These decisions may pose serious health risks, including potential injury or death,” the FDA stated in its announcement. The sensors are designed to measure glucose levels in interstitial fluid beneath the skin, providing real-time data to users via a connected device or smartphone.
Abbott officials reported that approximately three million sensors from a single production line in the U.S. are affected by the warning. The company clarified that about half of these devices have either expired or been used. As of November 14, 2023, Abbott has documented seven deaths globally and 736 serious adverse events related to the sensors. Notably, no fatalities have been reported in the U.S., although 57 injuries have been attributed to the malfunctioning devices.
Specifics on Affected Models
The FDA has identified specific models that pose a risk. This includes the FreeStyle Libre 3 sensors with model numbers 72080-01 and unique device identifiers 00357599818005 and 00357599819002. Additionally, the FreeStyle Libre 3 Plus sensors with model numbers 78768-01 and 78769-01 are also included, using unique device identifiers 00357599844011 and 00357599843014.
Abbott has taken steps to inform all customers about the issue and has assured that it has identified and resolved the problem in the affected production lot. The FDA advises individuals currently using these sensors to stop their use immediately and to dispose of them safely.
For those who may be affected, Abbott has provided a resource at www.FreeStyleCheck.com where users can verify if their sensors are part of the recall and request replacements. Importantly, the warning does not extend to other FreeStyle Libre products, ensuring that a broader range of users can continue to utilize unaffected devices.
As the situation develops, both the FDA and Abbott remain committed to ensuring user safety and maintaining transparency regarding the performance of their medical devices.
