Abbott issues urgent correction for FreeStyle Libre 3 sensors

Abbott Laboratories has issued an urgent medical device correction concerning its FreeStyle Libre 3 sensors. The announcement on the company’s official website highlights a defect in a specific batch of sensors that could lead to inaccurate high glucose readings. Although limited to a small subset of the sensors, this issue has significant implications for users, particularly those managing diabetes.

The FreeStyle Libre 3 system, which comprises a sensor, reader, and app, has been widely adopted by individuals with diabetes due to its advanced glucose monitoring capabilities. However, Abbott’s latest communication specifies that the problem is confined to the sensors alone, with the FreeStyle Libre 3 reader and app remaining unaffected. Moreover, users of other versions such as the FreeStyle Libre 14 day, FreeStyle Libre 2, and FreeStyle Libre 2 Plus sensors can rest assured that their devices are not impacted.

Abbott’s investigation revealed that a small number of FreeStyle Libre 3 sensors might provide incorrect high glucose readings. If undetected, these erroneous readings could lead to inappropriate treatment decisions, such as unnecessary insulin administration, posing potential health risks.

The affected sensors have been traced back to three specific lot numbers:

• T60001948
• T60001966
• T60001969

To mitigate potential risks, Abbott has provided clear directions for users to determine if their sensor is part of the affected batch. Users are advised to visit Abbott's website's Confirm Sensor Serial Number page and enter their sensor’s serial number. If the sensor is identified as part of the impacted lot, users will be guided through obtaining a replacement at no cost. Abbott has emphasized the importance of discontinuing affected sensors immediately and disposing of any remaining sensors from the mentioned lot numbers.

For current users of the FreeStyle Libre 3 system experiencing symptoms that do not align with their sensor glucose readings or suspect inaccuracies, Abbott recommends conducting a fingerstick test using any blood glucose meter. The built-in blood glucose meter in the FreeStyle Libre 3 reader can also be used for verification anytime.

Abbott has proactively informed the US Food & Drug Administration (FDA) about this issue and ensures that affected users are promptly notified and provided with replacements. Users with additional questions or need to report adverse reactions or quality problems associated with the sensors are encouraged to contact Abbott customer service at 1-833-815-4273. The customer service line is operational seven days a week from 8 am to 8 pm Eastern Time, excluding holidays. Reports can also be submitted to the FDA’s MedWatch Adverse Event Reporting program through their online form, by calling 1-800-FDA-1088, or by faxing to 1-800-FDA-0178.

This incident underscores the critical nature of accurate glucose monitoring for diabetes management. Inaccurate readings can lead to severe health consequences, and Abbott’s swift response aims to prevent such occurrences. The company has expressed sincere apologies for the inconvenience caused and is committed to resolving the issue efficiently.

For healthcare technology stakeholders, this development highlights the importance of rigorous quality control and prompt corrective actions in medical devices. The FreeStyle Libre 3 system, known for its innovative approach to glucose monitoring, must now navigate this challenge to maintain user trust and ensure the safety and well-being of its users.

As the situation develops, healthcare providers, patients, and technology partners will closely monitor Abbott’s handling of the correction process. The company’s ability to manage this issue effectively will be crucial in maintaining its reputation as a leader in diabetes care technology.

For more detailed information and updates, users are advised to visit Abbott’s official FreeStyle Libre website and follow the instructions to verify their sensor’s status and request replacements if necessary.