Abbott is addressing a critical issue affecting certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors distributed in the United States. This action follows internal findings that some sensors may provide inaccurate low glucose readings, which could lead people living with diabetes to make potentially harmful treatment decisions. This correction is essential for safeguarding patient health and ensuring accurate glucose monitoring.
What changed?
Abbott’s internal testing revealed that a specific production line for FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors may have caused certain sensors to display incorrect low glucose readings. This issue could result in improper management actions, such as unnecessary carbohydrate consumption or missed insulin doses. Although Abbott swiftly resolved this manufacturing issue, approximately 3 million sensors from the affected line were distributed in the U.S., with about 50% of those already expired or used.
Globally, Abbott received 736 reports of severe adverse events potentially linked to this issue, including seven deaths, though none occurred in the U.S. In the U.S., 57 adverse events were reported. It is critical for users to confirm whether their sensor is potentially affected and take the necessary steps to mitigate risks.
Who is affected?
This medical device correction impacts specific batches of FreeStyle Libre 3 and Libre 3 Plus sensors distributed in the U.S., as well as other international markets. Other products in Abbott’s Libre portfolio, including the FreeStyle Libre 14 day, FreeStyle Libre 2, and Libre Pro sensors, remain unaffected. Similarly, FreeStyle Libre 3 readers and mobile applications are not impacted by this correction.
Abbott is offering free sensor replacements for all impacted devices. Consumers can visit www.FreeStyleCheck.com or contact Abbott customer service for verification and assistance.
What steps should users take?
Users of FreeStyle Libre 3 or Libre 3 Plus sensors should:
- Visit www.FreeStyleCheck.com to check if their devices are among the potentially affected batches.
- Stop using any confirmed impacted sensors immediately, dispose of them safely, and request a free replacement through Abbott.
- Until replacement sensors are obtained, use a blood glucose meter or the built-in meter in the FreeStyle Libre 3 reader to confirm readings before making treatment decisions.
Abbott’s customer service team is available at 1-833-815-4273 to provide further guidance. Live chat assistance is also offered 24/7 at Abbott Support.
Key safety and regulatory details
Abbott has affirmed resolving the manufacturing issue responsible for this error. Production continues on other lines to meet the demand for Libre 3 and Libre 3 Plus sensors, ensuring minimal supply disruptions. Patients and healthcare providers outside the U.S. can access information and guidance from the same online verification tool at www.FreeStyleCheck.com.
The intent behind this correction aligns with medical device regulations to prioritize safety, accuracy, and performance. Consumers and clinicians are urged to exercise vigilance and follow the outlined recommendations for smoothing this transition while avoiding adverse outcomes.
Conclusion
Abbott’s proactive correction action underscores its commitment to patient safety and the performance of its diabetes management devices. If you or someone you know uses FreeStyle Libre 3 or Libre 3 Plus sensors, taking timely action to verify and replace potentially impacted devices is crucial for your health management.
Disclaimer
This article does not constitute legal or medical advice. Always refer to official sources and consult professionals when addressing regulatory and health matters.