FDA, Abbott warn Libre 3 sensors can give false lows; 7 deaths, 736 injuries
The FDA and Abbott warned that some FreeStyle Libre 3 continuous glucose monitoring sensors can produce falsely low glucose readings, a problem linked to seven deaths and 736 serious injuries. Abbott said all seven deaths occurred outside the U.S., 57 of the 736 injuries were reported in the U.S., about 1.5 million of roughly 3 million affected sensors are estimated to have already expired or been used, and users should immediately stop using and dispose of affected lots, verify lot numbers at FreeStyleCheck.com, and request free replacements.
📌 Key Facts
- The FDA and Abbott warned that FreeStyle Libre 3 continuous glucose monitor sensors can give falsely low glucose readings.
- Abbott and regulators have linked seven deaths to the affected Libre 3 sensors; all seven occurred outside the United States.
- There have been 736 severe injuries reported worldwide linked to the sensors, 57 of which occurred within the United States.
- About 3 million Libre 3 sensors are affected; roughly 1.5 million of those are estimated to have already been used or expired.
- Abbott has directed users to immediately discontinue and dispose of affected sensors, to verify lot numbers at FreeStyleCheck.com, and is offering free replacements.
📊 Relevant Data
In the United States, the prevalence of diagnosed diabetes among adults is 13.6% for American Indian and Alaska Native adults (who make up 0.9% of the population), 12.1% for non-Hispanic Black adults (12.1% of the population), 11.7% for Hispanic adults (18.7% of the population), 9.1% for Asian adults (5.9% of the population), and 6.9% for non-Hispanic White adults (57.8% of the population).
Non-Hispanic Black, Hispanic, and other adults had a 47%, 31%, and 76% higher prevalence of diabetes than non-Hispanic White adults, with adults from low socioeconomic status having 87% higher prevalence than those from high socioeconomic status.
Unveiling inequalities: Racial, ethnic, and socioeconomic disparities in diabetes prevalence in the United States — Preventive Medicine Reports
A genetic variation common in people of African ancestry is associated with an increased risk of complications from diabetes, including diabetic retinopathy.
Gene variant may underlie diabetes disparities: study — VUMC News
📰 Sources (2)
- Of the 736 severe injuries reported, 57 occurred within the United States.
- Approximately 1.5 million of the ~3 million affected sensors are estimated to have already expired or been used.
- Reiterates Abbott’s directive to immediately discontinue and dispose of affected sensors and to verify lots at FreeStyleCheck.com, with free replacements offered.
- Confirms all seven linked deaths occurred outside the U.S.