Abbott Issues Voluntary Correction for FreeStyle Libre Readers

BY Oliver Lester

Abbott, a global healthcare company, has initiated a voluntary medical device correction for its FreeStyle Libre Readers in the United States due to a limited number of reports worldwide (0.0017%) from users over several years that their reader’s lithium-ion battery swelled, infrequently overheated or, in very rare cases, sparked or caught fire. While no physical recall is being made, Abbott is advising customers on proper storage, charging, and use of the Readers and their accompanying USB cable and power adapter to avoid potential hazards.

The FreeStyle Libre Reader is a small handheld device that collects real-time glucose readings directly from a sensor worn on the back of a person’s upper arm, allowing them to manage their diabetes by seeing their glucose readings on a screen. Users can also use a compatible smartphone app to receive their glucose data, but switching to the app requires starting a new sensor.

To prevent potential battery swelling, leakage, extreme overheating, and fire, Abbott recommends customers to follow the steps outlined below and on their website:

• Charge the Reader battery using only the Abbott-supplied yellow USB cable and adapter (charger).
• Do not charge the Reader with non-Abbott adapters or non-Abbott USB cables concurrently with misuse of the Reader and its components, which includes exposure to liquids, damage, and the introduction of foreign material into the ports.
• Do not expose the Reader, power adapter, or yellow USB cable to water or other liquids.
• Store the Reader between -4°F and 140°F.
• Do not place the Reader in water or other liquids.
• Avoid getting dust, dirt, blood, control solution, water, bleach, or any other substance in the test strip or USB port.

Abbott has been notifying customers of this matter since February through a variety of communication methods, including email and letters. The communication to customers was done voluntarily, and the U.S. Food and Drug Administration has been informed.

Since the launch of FreeStyle Libre Readers in the U.S. in 2017, there have been no reported incidents that have caused serious adverse health consequences or death due to this issue. As previously communicated to Reader customers, if a Reader is stored, charged, and used properly, then risks are mitigated.

If customers have questions or want to learn how to test their Reader as well as properly store, charge, and use their Reader and its USB cable and power adapter, they’re encouraged to review the Perform a Reader Test section of the Reader User Manual, visit www.FreeStyleBattery.com, or contact Abbott’s Customer Service at 1-855-632-8658. Agents are available to help customers seven days a week from 8 a.m. to 8 p.m. Eastern Time, excluding major holidays.

The medical device correction does not affect any of the FreeStyle Libre family of sensors. Customers can continue to use their Readers with the Abbott-provided USB cable and power adapter.

Abbott is committed to user safety and ensuring that their products meet the highest standards of quality and reliability. The voluntary medical device correction is part of their ongoing efforts to provide their customers with safe and effective products for diabetes management.

Abbott has taken a responsible and proactive approach by issuing a voluntary medical device correction for its FreeStyle Libre Readers due to a battery issue, emphasizing the importance of proper storage, charging, and use to avoid potential hazards. While no physical recall is being made, customers are encouraged to review the revised user guide and labeling, perform a Reader Test, and contact Abbott’s Customer Service if they have any questions or concerns. By taking these steps, Abbott is demonstrating its commitment to customer safety and ensuring that people with diabetes can continue to manage their condition effectively using the FreeStyle Libre Reader.