Glucose monitor errors may be linked to 7 deaths and hundreds of injuries

Health authorities are urging patients to discontinue use of certain Abbott Diabetes Care glucose monitors after the company discovered defective sensors potentially linked to hundreds of adverse incidents and several fatalities, according to the Food and Drug Administration (FDA) on Tuesday.

Abbott's internal tests revealed that some sensors in specific FreeStyle Libre 3 and FreeStyle Libre 3 Plus models might display inaccurately low glucose readings, the company stated in a press release. Reports indicate 736 adverse events potentially associated with this problem, including 57 in the United States. Seven deaths, occurring outside the U.S., may be connected to the sensor malfunction.

The FDA described the defect as a "potentially high-risk issue." Since people with diabetes rely on glucose readings to manage insulin and diet, incorrect low values could result in excessive carbohydrate consumption or missed insulin doses, which "may pose serious health risks, including possible injury or death," Abbott warned.

The problem affects sensors from a single production line among those manufacturing Libre 3 and Libre 3 Plus devices. Approximately three million devices are implicated, although about half are already expired or used. Users should verify their sensor's model number and unique device identifiers to determine if it is affected.

The impacted FreeStyle Libre 3 sensor model numbers are 72081-01 and 72080-01, with unique device identifiers 00357599818005 and 00357599819002. For FreeStyle Libre 3 Plus, the affected model numbers are 78768-01 and 78769-01, with identifiers 00357599844011 and 00357599843014. A complete list of affected lots is available on the FDA's website.

Abbott and the FDA recommend that anyone with an affected device stop using it immediately. Free replacement sensors can be requested through www.FreeStyleCheck.com. In cases where sensor readings do not align with expected glucose levels or symptoms, patients should rely on a blood glucose meter or the built-in meter on a FreeStyle Libre 3 Reader for treatment decisions.

The issue does not affect FreeStyle Libre 3 readers, mobile apps, or any other Libre-brand sensors. Abbott confirmed that the root cause has been identified and resolved, and no disruption to supply is anticipated.

Author: Logan Reeves