After Abbott warned users of its FreeStyle Libre diabetes monitoring hardware earlier this week of the possibility of dangerous battery issues—including swelling, overheating, sparking and catching fire—the FDA has dubbed the replacement efforts as a Class I recall.
Though not a true recall requiring all affected continuous glucose monitors to be returned to the manufacturer, the FDA said in its announcement that the battery issues could, in rare cases, turn severe enough to cause serious injuries or even death.
The agency recommended that owners stop using their devices and switch to a backup if there is any visible swelling in the hand-held reader, if it becomes too hot to hold or is unable to hold a charge. Both the FDA and Abbott have urged users to only charge their readers using the provided power adapter and USB cable.
The issue affects the data-collecting readers used in the FreeStyle Libre, FreeStyle Libre 14 day, and FreeStyle Libre 2 Flash systems, amounting to more than 4.2 million devices across the U.S., according to the FDA. The recall does not impact any FreeStyle Libre blood sugar sensors.
Abbott and the agency have said that the risk of overheating and fire can increase when charging the reader’s lithium-ion batteries with third-party adapters and cables—which may deliver a higher rate of electricity—as well as if the devices are not properly stored or exposed to liquids, damage or extreme temperatures.
According to the FDA, Abbott has reported a total of 206 incidents, including at least seven fires, one injury and no deaths. The company described the reports as affecting 0.0017% of the total devices in use worldwide.
The FreeStyle Libre reader collects glucose data from the sensor worn on the back of a person’s upper arm. Users can rely on a smartphone app instead, but switching would require starting with a new sensor. The company launched a dedicated website—www.freestylebattery.com—with more information and steps on how to test a reader’s battery to see whether it needs to be replaced.