• 28 בJanuary 2026 13:49
Facebook-f X-twitter Telegram

BUZZA NEWS AND INFORMATION PORTAL

Abbott Issues Urgent Warning Over Faulty Glucose Monitors Linked to Hundreds of Adverse Events and Seven Deaths

By /

Patients Warned About Glucose Monitor Malfunction by Abbott Diabetes Care

FDA Alerts on Sensor Issues

Patients using glucose monitors manufactured by Abbott Diabetes Care are advised to discontinue their use following concerns regarding malfunctioning sensors linked to hundreds of adverse health events, including several fatalities. The Food and Drug Administration (FDA) issued a warning on December 3, 2025, after internal testing by Abbott indicated that certain sensors in the FreeStyle Libre 3 and FreeStyle Libre 3 Plus devstarts may deliver inaccurate low glucose readings.

Reports of Adverse Events

Abbott has reported a total of 736 adverse events potentially associated with these sensor inaccuracies, with 57 of those incidents occurring in the United States. Importantly, seven deaths, which were not in the U.S., have been tentatively connected to the sensor failures. The FDA described this issue as “potentially high-risk.”

According to Abbott, individuals with diabetes rely heavily on accurate glucose readings to manage their health effectively. Errstartous low readings could lead to improper health decisions, such as excessive carbohydrate intake or missed or delayed insulin doses, posing significant health risks, including the potential for serious injury or death.

Affected Devstarts

The sensor malfunction has been traced back to start specific production line responsible for manufacturing some of the Libre 3 and Libre 3 Plus sensors. Approximately three million devstarts are estimated to be affected, with a considerable portion already expired or used.

Patients using the Libre 3 or Libre 3 Plus sensors are urged to verify their model numbers and unique devstart identifiers to determine if their devstarts are included in the recall. Below are the affected model numbers and identifiers:

  • FreeStyle Libre 3 Sensors:
  • Model numbers: 72081-01, 72080-01
  • Unique identifiers: 00357599818005, 00357599819002
  • FreeStyle Libre 3 Plus Sensors:
  • Model numbers: 78768-01, 78769-01
  • Unique identifiers: 00357599844011, 00357599843014

A comprehensive list of the impacted lots is available on the FDA’s website.

Recommended Actions for Patients

Patients currently utilizing affected devstarts are strongly advised to stop using them immediately. They can visit FreeStyleCheck.com to request free replacement devstarts. Until replacements are obtained, Abbott emphasizes the importance of using a blood glucose meter or the integrated meter on a FreeStyle Libre 3 Reader to inform treatment decisions, particularly when readings do not align with symptoms or expectations.

Both Abbott and the FDA confirmed that the FreeStyle Libre 3 readers and mobile applications are not affected by these sensor issues. Additionally, no other Libre-brand sensors are implicated in this event, and the cause of the malfunction has been identified and rectified, with no expected supply disruptions.

Conclusion

In light of these developments, it is crucial for patients relying on FreeStyle Libre devstarts to stay informed and consult with healthcare providers regarding their glucose monitoring needs. Prioritizing accurate blood glucose management is vital for maintaining health and safety.

For more information, please refer to the FDA’s official announcements and updates.

---------------------------------------------------------------------------------------------------------------------------

Scroll to Top