FDA Links Glucose Monitor Errors to 7 Deaths, Hundreds of Injuries
The Food and Drug Administration (FDA) has issued a significant warning regarding specific glucose monitoring devices manufactured by Abbott Diabetes Care. After internal testing, Abbott confirmed that some sensors linked to the FreeStyle Libre 3 and FreeStyle Libre 3 Plus devices may provide inaccurate low glucose readings, which could pose serious health risks.
Link to Adverse Events and Deaths
Abbott reported a total of 736 adverse events associated with these malfunctioning sensors. Out of these, 57 incidents occurred within the United States, and seven deaths – none occurring in the U.S. – were potentially connected to this sensor malfunction. The FDA termed this issue a “potentially high-risk” circumstance, emphasizing the danger posed to patients whose diabetes management relies heavily on accurate glucose readings.
Health Risks of Inaccurate Readings
Patients with diabetes depend on precise glucose levels to make informed decisions about carbohydrate intake and insulin dosing. Inaccurate low readings could lead to improper management, resulting in excessive intake of carbohydrates or delayed insulin administration, thereby increasing the likelihood of injury or even death.
Devices and Production Line Affected
The malfunction was traced back to one specific production line responsible for manufacturing the impacted Libre 3 and Libre 3 Plus sensors. Approximately three million devices are estimated to be affected, with about half of them already expired or used.
Identifying Affected Devices
Users should verify whether their device is among those recalled by checking model numbers and unique device identifiers:
- FreeStyle Libre 3 (Model Numbers):
- 72081-01 (UID: 00357599818005)
- 72080-01 (UID: 00357599819002)
- FreeStyle Libre 3 Plus (Model Numbers):
- 78768-01 (UID: 00357599844011)
- 78769-01 (UID: 00357599843014)
For a complete list of affected lots, patients are encouraged to visit the FDA’s official website.
Recommendations for Patients
Those using the affected Libre 3 or Libre 3 Plus sensors must cease usage immediately. Abbott and the FDA recommend utilizing a standard blood glucose meter or the built-in meter of the FreeStyle Libre 3 Reader when sensor readings do not align with actual symptoms or expectations. Patients may request free replacement devices through the Abbott website.
Assurance from Abbott
Abbott has confirmed that the FreeStyle Libre 3 readers and mobile applications remain unaffected. Additionally, there are no disruptions expected in the supply of Libre-brand sensors as the issue has been identified and resolved.
