Abbott FreeStyle Libre safety alert: affected parts and other details explored

Abbott initiated a nationwide voluntary medical device correction in February to emphasize instructions for the safe and proper use of its FreeStyle Libre®, FreeStyle Libre® 14 day, and FreeStyle Libre® 2 Readers in the United States.

The correction and/or safety alert was issued after the company received a limited number of global reports (over 0.0017%) from users who found that the lithium-ion batteries on the devices either swelled, infrequently overheated or in very rare cases, sparked or caught fire.

Considering the minimal risks, no Freestyle readers are being physically recalled and customers can continue to use them as described in the instructions.

the company is urging all customers to charge the Freestyle readers only with company-provided yellow cable chargers and adapters (Image via Abbott Freestyle)

Like most electronic devices, the concerned Freestyle Libre Readers are equipped with lithium-ion batteries. While the batteries are rechargeable and last for a very long time, they can often end up swelling and may overheat when the device is charged with incompatible chargers. The company is urging customers to charge the devices only with an Abbott-provided USB cable and the power adapter to ensure the safety of the devices.

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All you need to know about Abbott FreeStyle Libre safety alert

As mentioned earlier, the safety alert and/or correction only applies to FreeStyle Libre®, FreeStyle Libre® 14 day, and FreeStyle Libre® 2 Readers in the United States. No other Freestyle readers or medical devices produced by Abbott are affected by the safety alert. Customers across the country can continue using the concerned devices as described in the instructions.

The Freestyle Family of Readers features small handheld devices that collect real-time glucose readings directly from a sensor worn on the back of a person’s upper arm. Freestyle readers allow people to manage their diabetes by looking at glucose readings on a screen.

Freestyle readers can also be used with the compatible smartphone app 1 to receive the glucose data. As mentioned earlier, Freestyle readers are powered by lithium-ion batteries which, if charged through unsupported chargers, can either swell or overheat and in rare cases, pose a fire risk.

However, all the risks related to concerned Freestyle readers, including - FreeStyle Libre®, FreeStyle Libre® 14 day, and FreeStyle Libre® 2 Readers - are mitigated as long as they are stored, charged, and used properly as per the communicated instructions.

Freestyle Family of Diabetes readers are subject to a voluntary correction to emphasize safe usage instructions (Image via Abbott Freestyle)

The company has not issued a physical recall of any of its Freestyle readers but is sharing proper usage and care instructions to ensure the safety of its customers. The instructions shared by the company are as follows:

1. Charge the Freestyle Family Diabetes Reader battery ONLY with the Abbott-supplied yellow USB cable and adapter (charger). The company-provided USB cable and power adapter are tuned in order to limit the current to safely charge the battery, whereas third-party components and chargers may allow a much higher power to flow through the lithium-ion battery, increasing the risk of fire.
2. Do not expose or place the Reader, power adapter or yellow USB cable to water or other liquids.
3. Store the Reader between -4 °F and 140 °F.
4. Avoid getting unwanted foreign materials such as dust, dirt, blood, control solution, water, bleach, or any other substance in the test strip or USB port on any of the Freestyle Family Diabetes Readers.
5. Review the revised user guide and labeling at www.freestyle.abbott/us-en/support.
6. Visit www.FreeStyleBattery.com and follow the steps to perform a Reader Test that will determine if your current Reader needs to be replaced.

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Abbott has been reaching out to all known customers about the issue since February through email and letters. As mentioned earlier, the concerned Freestyle readers are not subject to a physical recall and are perfectly safe for usage when customers follow the instructions outlined at www.FreeStyleBattery.com. Ever since the launch of FreeStyle Libre Readers in the U.S. in 2017, the company has received no reports of incidents or fatalities due to this issue.

Customers with doubts and queries about the Freestyle readers or any other similar issue can get in touch with Abbott’s Customer Service at 1-855-632-8658. Agents are available to assist customers seven days a week from 8 am to 8 pm Eastern Time, excluding major holidays.