Abbott Glucose Sensors Linked to Serious Health Risks

Abbott Diabetes Care has issued a warning for patients using certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus glucose monitoring sensors. Internal testing revealed that some sensors may inaccurately display low glucose readings, a potentially high-risk issue identified by the Food and Drug Administration. This malfunction has been linked to 736 adverse events worldwide, including seven reported deaths, although none occurred in the United States. The affected devices stem from a single production line, impacting approximately three million sensors, with about half estimated to have already expired or been used.

Individuals relying on these glucose readings for diabetes management face serious health risks if they act on incorrect low numbers. Such decisions could lead to excessive carbohydrate intake or missed insulin doses, potentially resulting in severe injury or death. Patients are urged to check their sensor's model number and unique device identifiers to determine if they are among the affected devices. The FDA and Abbott have provided specific model and identifier numbers for reference on the FDA's website.

Abbott and the FDA are advising all users with an impacted device to cease its use immediately. Free replacement sensors can be requested online. In instances where sensor readings do not align with a patient's symptoms or expectations, it is recommended to use a blood glucose meter or the built-in reader for treatment decisions. Abbott has confirmed the cause of the sensor issue has been identified and rectified, with no anticipated supply disruptions. Importantly, FreeStyle Libre 3 readers and mobile applications remain unaffected, as are all other Libre-brand sensors.