Health care giant Abbott issued a warning impacting four million readers for glucose monitors after reports that devices were overheating and catching fire when patients used non-Abbott charging cords. The company said that customers do not need to return the readers, but cautioned against using cords other than those provided by Abbott.
In a notice posted Thursday, the Food and Drug Administration identified the problem as a Class 1 recall, which signals that use of a device might cause serious injury. The warning includes readers for several different models of Abbott’s FreeStyle Libre glucose monitors, which help people with diabetes monitor their blood glucose levels regularly without finger pricks. The sensors used in the devices are not impacted, the FDA said.
The devices use rechargeable lithium-ion batteries and come with Abbott-provided USB cable and power adapter. When people used non-Abbott charging cords, the battery can spark and catch fire. Abbott reported 206 incidents of the device malfunction, including at least seven fires and one injury. The company has not reported any deaths due to the issue.
An Abbott spokesperson said the company has been communicating with customers since February, when the company first warned of safety risks. The products impacted include the FreeStyle Libre, Libre 14 day, and Libre 2 Flash Glucose Management Systems.
The FDA recommends that people stop using their FreeStyle systems if they do not have an Abbott-provided power cord, if the device becomes too hot to hold, if the device shows visible swelling or cracks, or if the device is no longer able to hold a charge.
The FreeStyle Libres have been sold across the country since November 2017.
At the JP Morgan Healthcare Conference in January, Abbott CEO Robert Ford said about 4.5 million people use the Libre device. The company plans to grow the monitor to become a $10 billion product over the next five years, Ford said.