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FDA warns of risk of overheating, fire with some FreeStyle Libre glucose monitors






CNN

At least seven fires and one injury related to some FreeStyle Libre glucose monitor products have prompted the US Food and Drug Administration to issue a Class I recall, the agency̵[ads1]7;s strongest, suggesting that use of a device could cause “serious injury or death” .”

The manufacturer, Abbott, says there have been 206 incidents related to these monitors since 2014. But no users have died from the problem, nor have there been any serious health consequences.

The problem affects more than 4.2 million devices across the United States, the FDA says.

Abbott initiated a voluntary medical device recall in February on its FreeStyle Libre, FreeStyle Libre 14 day and FreeStyle Libre 2 Readers in the United States due to reports from some users that the readers’ lithium-ion batteries swelled, overheated and, in some cases, generated sparks or even caused a fire.

“No FreeStyle Libre readers are physically recalled and customers can continue to safely use their readers with the Abbott-supplied USB cable and power adapter. Customers do not need to return their readers. The steps outlined at www.FreeStyleBattery.com provide guidance on how to should properly store, charge and use a reader and the included USB cable and power adapter, Abbott told CNN in an email. Friday.

The company sent letters to some users of the FreeStyle Libre readers on February 13.

People with diabetes use glucose monitors to check their blood sugar levels because of problems with how their bodies make or use insulin, a hormone that helps blood sugar enter cells, where it is used for energy. Without insulin, sugar can build up in the blood and break down the body’s own fat and muscles.

A continuous glucose monitor uses a hand-held device that reads a sensor placed on the back of the person’s upper arm to capture glucose levels in real time.

The display used with the FreeStyle Libre line uses lithium-ion batteries similar to a cell phone. The battery is charged with a yellow USB cable that Abbott supplies with the equipment and which limits electrical current to charge the battery safely. Use of other USB cables or power adapters, along with misuse of the equipment such as damage or exposure to liquids, may increase the risk of fire, the FDA’s recall says.

The problem only involves the reader, not the sensor that the person wears on their arm.

Unlike more common recalls where customers are asked to discard or return their items, these types of fixes instruct users to continue using their devices, but only with the equipment provided to charge the device. The equipment should also be stored properly between temperatures of -4 and 140 degrees Fahrenheit. The reader should never be placed in water, and the USB port should be kept clean. More information is available in the device’s user guide.

Users of these glucose monitoring devices also have the option of using an app on their phone to receive the glucose data, but this requires a new sensor, the FDA said.

Customers who have questions or would like to learn about testing, charge storage or using the reader can visit www.FreeStyleBattery.com or contact Abbott Customer Service at 1-855-632-8658. Customers can also contact Abbott if they need a new power adapter or yellow USB cable.



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