Abbott FreeStyle Libre Glucose Monitor Warning Issued Over Battery Problems, Overheating Risks

Federal regulators are warning about reports of problems with FreeStyle Libre glucose monitors, which have lithium ion batteries that may overheat, leak and catch fire.

The U.S. Foods and Drug Administration (FDA) issued the FreeStyle Libre warning on April 3, following a safety notification issued by the manufacturer in February.

Abbott has indicated it is aware of incidents of the FreeStyle Libre overheating, leaking and even causing fires. However, the manufacturer maintains the problem has not been linked to any serious adverse health effects or patient injuries. No Abbott FreeStyle Libre recall has been announced as a result of the risk.

According to the warning, if the readers are not charged with the manufacturer provided charging cable, the lithium-ion battery could receive too much power, increasing fire and overheating risks. Lithium ion batteries have been an ongoing concern for years, with the U.S. Consumer Product Safety Commission (CPSC) having announced numerous recalls due to the devices being prone to overheating, smoldering catching on fire and even exploding.

Over the last several years, loosely regulated lithium-ion batteries manufactured without a high degree of quality control have been used to power a variety of popular consumer products, such as hoverboards, e-scooters, e-bikes, vaping pens, laptop battery packs, electric vehicles, and various other devices that require portable power. However, the CPSC has received an overwhelming amount of adverse events linked to these poorly manufactured lithium ion batteries, including short circuiting and thermal runaway events, which have resulted in hundreds of serious injuries, some of which requiring hospitalization and even resulting in death.

The FreeStyle Libre system is designed to help consumers monitor their blood glucose levels in real-time and manage their diabetes using a sensor on the consumer’s arm that sends glucose readings directly to the either the handheld device or an application on the consumer’s smartphone.

According to the warning, consumers may continue using their FreeStyle Libre, FreeStyle Libre 14 day, and FreeStyle Libre 2 Flash Glucose Monitoring Systems, but should implement the following safety recommendations:

• Only use the yellow USB cable and adapter provided with the device to charge the glucose reader battery.
• Keep all liquids, substances and foreign objects away from the testing strips, monitor, USB charging port, cable, and adapter.
• Ensure the device is stored between -4 °F and 140 °F.
• Visit freestyle.abbott/us-en/support and review the revised user guide.
• Visit FreeStyleBattery.com to see if your current device should be replaced.

For more information or to receive replacement accessories, consumers may contact Abbott customer service at 1-855-632-8658 any day of the week from 8 A.M. to 8 P.M. ET, except on major holidays. They can also visit www.FreeStyleBattery.com.