Using This Glucose Monitor? FDA Warns Of Faulty Sensors Linked To Seven Deaths — What Users Must Know

The United States Food and Drug Administration (USFDA) has issued a directive urging citizens to discontinue certain glucose monitoring sensors after Abbott Diabetes Care reported that these defective devices may be connected to the deaths of at least seven people. 

“Abbott Diabetes Care stated that certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors provide incorrect low glucose readings. If undetected, incorrect low glucose readings over an extended period may lead to wrong treatment decisions for people living with diabetes, such as excessive carbohydrate intake or skipping or delaying insulin doses,” the USFDA said on its website.

“These decisions may pose serious health risks, including potential injury or death, or other less serious complications,” the US drug regulator added.

Till Nov. 14, Abbott Diabetes Care has reported 736 serious injuries and seven deaths associated with this issue, the FDA said. 

Roughly 30 lakh FreeStyle Libre 3 and Libre 3 Plus sensors could be generating wrong low glucose readings, potentially prompting people with diabetes to take inappropriate action, Abbott Diabetes Care has said.

“Abbott has identified and resolved the cause of the issue, which relates to one production line among several that make Libre 3 and Libre 3 Plus sensors…This action involves approximately 3 million Libre 3 and Libre 3 Plus sensors in the US from that production line, about half of which are estimated to have expired or been used. Globally, Abbott has received reports of 736 severe adverse events (57 in the US) and seven deaths (none in the US) potentially associated with this issue,” the company said.

Users of these devices should visit www.FreeStyleCheck.com to determine whether their sensor is among those impacted by the issue. Abbott is offering free replacements for all affected units. The website provides step-by-step instructions for verifying sensors and submitting replacement requests. 

If a sensor is confirmed as potentially faulty, whether through the online tool or customer service, users are urged to stop using it and discard it.

“Consumers should use a blood glucose meter or the built-in meter in the FreeStyle Libre 3 reader to make treatment decisions when sensor readings don’t match symptoms or expectations,” the pharma company advised diabetes patients.