Abbott shares safety concerns with millions of CGM sensors—7 deaths reported
Abbott has announced a large medical device correction aimed at replacing certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors. The announcement came after internal testing identified an issue with some devices providing incorrect glucose readings.
Approximately 3 million CGM sensors are impacted by this potential problem. According to Abbott, the source of the issue—which has already been corrected—was a specific production line.
The company emphasized that incorrect glucose readings are associated with multiple risks.
“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,” according to a statement. “These decisions may pose serious health risks, including potential injury or death, or other less serious complications.”
In total, Abbott has received reports of 736 severe adverse events and seven deaths that are potentially related to these sensor issues. Fifty-seven of those severe adverse events, and none of the deaths, occurred in the United States.
Recommendations for consumers
Consumers are asked to visit www.FreeStyleCheck.com to confirm whether or not their sensor is potentially affected by this medical device correction. Abbott will replace sensors as necessary at no charge. Anyone currently wearing a sensor that is part of this correction should stop using it immediately.
The U.S. Food and Drug Administration (FDA) has not announced any recalls associated with this ongoing medical device correction. If the FDA does finalize any recalls, Cardiovascular Business will share that information.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.