Abbott Recalls Some FreeStyle Libre Readers Over Battery Issues

The U.S. Food and Drug Administration (FDA) has identified Abbott’s February 13 recall of its FreeStyle Libre Flash glucose monitoring system, FreeStyle Libre 14 day Flash glucose monitoring system, and FreeStyle Libre 2 Flash glucose monitoring system as Class I.
 
These systems are intended to offer continuous glucose level monitoring. They help patients manage diabetes by spotting trends and tracking patterns in glucose levels so treatment can be adjusted as necessary.
 
Abbott recalled the systems due to their reader devices that use rechargeable lithium-ion batteries may get very hot, spark, or catch fire if not correctly stored, charged, or used with its Abbott-provided USB cable and power adapter. This issue doesn’t affect any of the FreeStyle Libre family of sensors.
 
The risk of overheating, spark, or fire can happen when charging the reader with non-Abbott adapters or USB cables along with Reader and component misuse—for example, exposure to liquids, damage, and foreign material being introduced into ports.
 
Abbott’s USB cable and power adapter limit the current for safe battery charging, whereas third-party USB cables and power adapters might allow much higher power, increasing fire risk. Further, improper Reader storage or charging can expose users to extreme heat and/or fire. Users may also delay or miss a critical diabetes treatment if the system can’t be used following heat damage.
 
Abbott reported 206 incidents of this issue, including seven fires and one injury. No deaths have been reported at this time.
 
The FDA recommended switching to a backup glucose monitoring method if users don’t have the Abbott-provided USB cable or charger, if the Reader appears damaged or cracked, the Reader shows visible swelling, the Reader gets too hot to hold, or the Reader is no longer able to hold a charge.