Abbott Laboratories, the makers of the FreeStyle Libre continuous glucose monitor (CGM), have announced a voluntary Class 1 recall for its readers due to a risk of battery failure and fire.
The Problem
A small number of Libre users have reported that their reader batteries have swelled and/or overheated. In very rare cases, this battery issue has caused fires, and it could conceivably cause serious injuries.
A Class 1 recall is defined by the U.S. Food and Drug Administration (FDA) as “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death,” though to date the reader flaw has not caused much serious harm. In its statement with the FDA, Abbott divulged that there have been “206 incidents, including at least seven fires, one injury, and no deaths involving this issue.”
The problem occurs when the lithium-ion battery is charged with an unapproved cable. Generic charging cables, or cables intended for other devices, can allow too much power to flow to the battery. If your battery gets contaminated in any way, this can create a fire risk.
Does the Recall Affect My FreeStyle Libre CGM?
The battery issue affects readers (a handheld device with a digital display), not sensors (the part that you stick to your body).
FreeStyle Libre readers are dedicated electronic devices that display blood sugar information and can be used with the FreeStyle Libre, FreeStyle Libre 14 Day, and FreeStyle Libre 2 systems. All readers distributed between November 2014 and today share the same problem.
If you use a smartphone to display your glucose data, rather than a reader, the recall doesn’t affect you.
I Have a FreeStyle Libre Reader. What Do I Do About It?
There is likely nothing wrong with the reader itself: It will continue to work as intended, and Abbott does not want you to send it in for a replacement if there is no sign of damage.
However, you should be very careful about how you recharge your reader. You should only use the yellow USB cable and power adapter that came in the original packaging with your reader. If you no longer have the official cable and power adapter, pictured below, get in touch with Abbott to receive a new one.
The official FreeStyle Libre reader adapter and cable
There is also a possibility that your reader has already sustained some damage due to this issue. To determine if you require a replacement, visit FreeStyleBattery.com and answer the “reader replacement check” questionnaire. If your reader has any signs of battery issues, Abbott may decide to send you a new one.
If your reader shows signs of swelling or overheating, stop using it immediately and get in touch with Abbott Laboratories, by visiting FreeStyleBattery.com or calling Abbott’s Customer Service at 1-855-632-8658.