Abbott (NYSE:ABT) initiated a voluntary medical device correction to emphasize instructions for FreeStyle Libre continuous glucose monitor (CGM) readers.
The instructions cover the FreeStyle Libre, Libre 14-day and Libre 2 readers in the U.S. Abbott received a limited number of global reports (0.0017%) from users over several years saying their reader’s lithium-ion battery swelled or infrequently overheated. In very rare cases, users reported that the battery sparked or caught fire.
A small, handheld device, the reader collects real-time glucose readings directly from a sensor worn on the back of the upper arm. It allows users to manage their diabetes by seeing their glucose readings on a screen. If users prefer, they may use a compatible smartphone app. To switch to the app, users must start a new sensor.
Abbott is not physically recalling any readers. Customers may continue using their readers with the company-provided USB cable and power adapter. The correction does not affect the FreeStyle Libre family of sensors, the company said. It began notifying customers in February through a variety of communication methods. This was done voluntarily and the FDA is involved, the company said.
Instructions from Abbott
To avoid the potential for battery issues, Abbott recommends that users charge the battery by only using company-supplied supplies. This features a yellow USB cable and adapter, comprising the “charger.” Issues may occur when charging the reader with non-Abbott adapters or USB cables. Other examples of misuse include exposure to liquids, damage and the introduction of foreign material into the ports.
The Abbott-provided cable and adapter limit the current to safety charge the battery, the company said. Third-party components may allow much higher power, increasing the risk of fire. Abbott also said to store the reader between -4 °F and 140 °F.
Since FreeStyle Libre readers launched in the U.S. in 2017, no reported incidents led to serious adverse health consequences or death due to the issue. Risks are mitigated if readers are stored, charged and used properly, Abbott said.