Abbott Issues Urgent Correction for Millions of Glucose Sensors Amid Safety Concerns

Abbott Laboratories has launched a significant medical device correction for approximately 3 million FreeStyle Libre 3 and Libre 3 Plus continuous glucose monitoring (CGM) sensors in the United States. The company's action comes in response to reports of incorrect low glucose readings, which have been associated with severe adverse events and deaths.

Scope and Impact of the Correction

The correction applies to Abbott's Libre 3 and Libre 3 Plus sensors, with about half of the affected devices estimated to have already expired or been used. Abbott has received reports of 736 severe adverse events globally, including 57 in the U.S., and seven deaths outside the country potentially linked to the issue.

The problem, traced to a manufacturing defect on a single production line, could lead to incorrect treatment decisions. Users might skip or delay insulin doses or consume excessive carbohydrates, posing serious health risks.

Company Response and Recommendations

Abbott has stated that it has resolved the root cause of the problem and does not anticipate supply disruptions. The company is offering to replace any potentially affected sensors at no charge to users. Abbott recommends that users:

1. Visit the company's website to check if their sensor is affected
2. Double-check readings with a separate blood glucose meter or the built-in meter on the Libre 3 reader
3. Be cautious when considering insulin doses if sensor readings don't match symptoms or expectations

Industry Context and Competitive Landscape

This is not the first time Abbott has faced challenges with its Libre line. In July 2023, the company recalled Libre 3 devices due to potentially incorrect high glucose readings. Similarly, competitor Dexcom has encountered issues with its latest glucose sensor, the G7, and recently recalled its older G6 device over a software problem.

These incidents highlight the ongoing challenges in the CGM market, where accuracy and reliability are paramount for patient safety. As companies continue to innovate and improve their devices, they must also navigate the complexities of quality control and regulatory compliance in this critical medical technology sector.