Abbott warns FreeStyle Libre users about rare cases of battery swelling, overheating
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Key takeaways:
- A voluntary medical device correction warned users of three Abbott FreeStyle Libre readers about the risk of battery swelling or overheating.
- No incidents with serious health consequences have been reported.
Abbott has issued a voluntary medical device correction to warn users about the potential for battery swelling, overheating or fire with three of its FreeStyle Libre readers.
According to a notice from the FDA, Abbott’s medical device correction was issued for the FreeStyle Libre, FreeStyle Libre 14-day and FreeStyle Libre 2 readers. The reader provides users with real-time glucose readings from their sensor, allowing them to manage their diabetes. According to the notice, there have been a limited number of reports from users over several years that the readers’ lithium-ion battery swelled, infrequently overheated, or in very rare cases, sparked or caught fire.
No readers have been recalled and Abbott said users can continue to use the readers with the USB cable and power adapters that are provided with the devices. Since the readers launched in the U.S. in 2017, there have been no reports of incidents causing serious adverse health consequences or death.
To avoid potential battery swelling, overheating or fire, Abbott recommends the following:
- Charge the reader battery by only using the Abbott-supplied USB cable and adapter.
- Do not expose the reader, power adapter or USB cable to water or other liquids.
- Avoid getting dust, dirt, blood, control solution, water, bleach or other substance on the test strip or USB port.
- Visit www.FreeStyleBattery.com to perform a reader test to determine if a current reader needs to be replaced.
Abbott has been notifying its customers of the matter since February through multiple methods, including by email and letters. Users are recommended to review Abbott’s revised user guide and labeling at www.freestyle.abbott/us-en/support.
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