Abbott Diabetes Care has recalled certain glucose monitoring sensors after reports of seven deaths and more than 700 injuries possibly linked to malfunctioning devices that could provide inaccurate readings.
The U.S. Food and Drug Administration announced Dec. 2 that Abbott issued a warning for some sensors in its FreeStyle Libre 3 and FreeStyle Libre 3 Plus devices. Internal testing by the company found the sensors could malfunction and provide incorrect low glucose readings.
The recall affects approximately 3 million sensors in the U.S. from a single production line, though Abbott estimates about half have already been used or expired. No other Libre products are impacted.
Abbott reported receiving 736 “severe adverse events” possibly linked to the monitors, including 57 in the U.S. The seven deaths were all reported outside the U.S. The FDA has classified the issue as “potentially high-risk.”
“Abbott initiated a medical device correction for certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors in the U.S. after internal testing determined that some of these sensors may provide incorrect low glucose readings,” the company said in a statement.
Abbott and the FDA are advising anyone using an affected device to stop immediately. Patients should use a blood glucose meter or the built-in meter on a FreeStyle Libre 3 Reader for treatment decisions if sensor readings do not match their symptoms.
“If undetected, incorrect low glucose readings over an extended period may lead to incorrect treatment decisions for people living with diabetes, such as excessive carbohydrate intake or skipping or delaying insulin doses,” the company said. “These decisions may pose serious health risks, including potential injury or death, or other less serious complications.”
Users can check if their sensor is affected by visiting www.FreeStyleCheck.com and entering their model number and unique device identifier.
The affected FreeStyle Libre 3 sensors have model numbers 72081-01 and 72080-01, with unique device identifiers 00357599818005 and 00357599819002. The affected FreeStyle Libre 3 Plus sensors have model numbers 78768-01 and 78769-01, with identifiers 00357599844011 and 00357599843014.
Abbott will replace all affected sensors at no cost. The company said it has identified and fixed the cause of the sensor issues and does not anticipate significant supply disruptions for new or replacement orders.
