FDA Issues Warning that Abbott’s FreeStyle Libre Readers May Overheat
By Arvind Sommi
A number of Libre users reported that their reader's lithium-ion battery swelled, overheated, sparked, and in rare cases, caught fire. In response, Abbott has issued a warning. If you use FreeStyle Libre, here are steps you can take to stay safe.
Abbott has issued a Class I recall, used when there is a risk of serious injury or death, for its FreeStyle Libre, Libre 14-day, and Libre 2 Flash Glucose Monitoring Systems. The recall affects all reader serial numbers distributed in the U.S. from November 2017 to February 2023, totaling 4,210,785 devices.
The recall is due to the potential overheating, sparking, or fire that may occur when the readers are charged with non-Abbott adapters or USB cables, or when they are damaged or exposed to liquids. Abbott-provided USB cables and power adapters limit the current to safely charge the battery, whereas third-party cables and adapters may allow much higher power, increasing the risk of fire.
Abbott emphasized that no readers should be returned to them. Readers can continue to be used as long as an Abbott-provided USB cable and power adapter are used and the reader is not damaged or cracked, not showing any visible swelling, is not too hot to hold, and is able to hold a charge.
Abbott has reported 206 incidents related to this issue, including at least seven fires and one injury, but no deaths. The FDA is advising people to stop using the FreeStyle Glucose Monitoring Systems and switch to a backup method if they do not have the Abbott-provided USB cable and power adapter, or if the reader appears damaged, cracked, or swollen. Additionally, if there is visible swelling of the reader, if the reader gets too hot to hold, or if the reader is no longer able to hold a charge, it is essential to switch to a backup.
If the Reader is damaged or an Abbott-provided USB cable or power adapter is needed, call Abbott's Customer Service at 1-855-632-8658 to request a replacement. The steps outlined at www.FreeStyleBattery.com provide guidance on how to properly store, charge and use a Reader and its accompanying USB cable and power adapter. This recall only applies to those using the external reader device, not those using their smartphone.
How to safely charge and use the reader
The FreeStyle Libre reader uses lithium-ion batteries, which are also used in mobile phones and many other handheld electronic devices. These batteries have the potential for swelling, leakage, or extreme overheating and may pose a fire hazard if not properly stored and charged. To avoid the potential for extreme overheating and/or fire, Abbott recommends the following:
Charge the reader battery by only using the Abbott supplied USB cable and adapter (charger). Charging the reader with non-Abbott adapters or non-Abbott USB cables may cause the problems noted above.
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.
Review the revised user guide and labeling at www.freestyle.abbott/us-en/support to ensure safe use of the device.
Visit www.FreeStyleBattery.com to follow steps to perform a Reader Test to determine if your current reader needs to be replaced.
By following these tips, people with diabetes who use the FreeStyle Libre systems can minimize the risk of fire or extreme heat and continue to monitor their glucose levels safely and effectively. Remember, it's important to take action if you notice any signs of damage or if you don't have the Abbott-provided USB cable and power adapter. Contact Abbott Customer Service at 1-855-632-8658 if you have any questions or concerns about the recall.