Faulty glucose monitors linked to 7 deaths, more than 700 injuries

The U.S. Food and Drug Administration has issued a warning regarding certain glucose monitor sensors produced by Abbott Diabetes Care. The company reported that these sensors, specifically the FreeStyle Libre 3 and FreeStyle Libre 3 Plus models, have been linked to seven deaths and over 700 injuries. The FDA stated that these sensors may provide incorrect low glucose readings, which could potentially lead individuals with diabetes to make harmful treatment decisions, such as consuming excessive carbohydrates or delaying insulin doses.

The affected sensors are designed to measure glucose levels in the fluid just beneath the skin, providing real-time blood sugar measurements. The information gathered by the sensor is transmitted wirelessly to a device or phone for monitoring. Abbott Diabetes Care confirmed that approximately three million sensors from a single production line in the U.S. are impacted by this issue. Half of these devices have either expired or been used, according to the company. As of November 14th, Abbott reported seven deaths globally and 736 serious adverse events, with no fatalities occurring in the U.S. and 57 injuries reported in the country.

Abbott has taken steps to address the problem by notifying all customers and resolving the issue in the affected production lot. The company advised individuals to discontinue the use of the affected sensors and dispose of them immediately. The specific models at risk include FreeStyle Libre 3 sensors with model numbers 72080-01 and unique device identifiers 00357599818005 and 00357599819002, as well as FreeStyle Libre 3 Plus sensors with model numbers 78768-01 and 78769-01 and unique device identifiers 00357599844011 and 00357599843014.

To determine if their sensors are potentially affected, individuals can visit the website www.FreeStyleCheck.com and request a replacement sensor if necessary. Abbott emphasized that no other FreeStyle Libre products are impacted by this issue. It is crucial for individuals using these glucose monitor sensors to take immediate action in response to the FDA warning to prevent any further health risks or complications.