FDA Issues Class I Recall of Abbott FreeStyle Readers for Risk of Overheating, Fire

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Announced on April 6, the recall, which is the most serious of its kind, includes all Readers used with the FreeStyle Libre, FreeStyle Libre 14 day, and FreeStyle Libre 2 Flash Glucose Monitoring Systems distributed from November 2017-February 2023, which totals more than 4 million devices in the US.

FDA logo in black over a white background | Courtesy: US Food and Drug Administration

Courtesy: US Food and Drug Administration

Editor's note: On April 12, 2023, the FDA updated its original announcement to note a medical device recall means a firm’s removal or correction of a medical device and, in Abbott’s case, the company was correcting the product labeling.

The US Food and Drug Administration (FDA) has issued a Class I recall for the Readers used with Abbott’s FreeStyle Libre, FreeStyle Libre 14 day, and FreeStyle Libre 2 Flash Glucose Monitoring Systems for risk of overheating and fire.

The recall includes all Reader serial numbers for devices distributed in the US between November 2017-February 2023 and comes after reports of 88 incidents, including at least 7 fires and 1 injury, but no deaths.1

In their own safety notification, Abbott pointed out no Readers are being physically recalled and customers can continue to safely use their Readers with the Abbott-provided USB cable and power adapter. Abbott also pointed out the 88 reports are representative of only 0.0017% of Readers sold worldwide.

“Abbott is recalling the FreeStyle Libre, Libre 14 day, and Libre 2 Flash Glucose Management Systems because the systems' reader devices, which use rechargeable lithium-ion batteries, may get extremely hot, spark, or catch on fire if not properly stored, charged, or used with its Abbott provided USB cable and power adapter,” reads the FDA recall notice.1

Announced by the FDA on April 6, 2023, the Class I Recall, which is the most serious type of recall, includes a total of 4,210,785 devices in the US.1 Coming just weeks after the announcement of clearance for its integrated sensors2, the company began to notify users of the FreeStyle Libre family of Readers in an Urgent Medical Device Correction letter beginning on February 13, 2023. In the announcement of the Class I Recall, the FDA pointed out the recall does not affect any of the FreeStyle Libre family of sensors.1

According to the release from the FDA, the administration recommends discontinuing use of the FreeStyle Glucose Monitoring Systems and switching to a back-up method if you do not have the Abbott provided USB cable and charger, the Reader appears damaged or cracked, there is visible swelling of the Reader, the Reader gets too hot to hold, or the Reader is no longer able to hold a charge.1

To minimize the risk of overheating, spark, or fire, Abbott recommends avoiding use of third-party charges, exposure to liquid, introduction of foreign material to ports, and improper storage. In their release, Abbott points out no Readers are being physically recalled and customers can continue to use their Readers with the Abbott-provided USB cable and power adapter.3 If the Reader is damaged or a replacement USB cable or power adapter are needed, customers are encourage to call Abbott's Customer Service at 1-855-632-8658 to request a replacement.

In a statement to HCPLive, Diana Isaacs, PharmD, director of Education and Training in Diabetes Technology at the Cleveland Clinic, noted it is important to keep this recall in perspective.

“While a Class I recall, may sound alarming, let's put this in perspective. Let's keep in mind that this was a voluntary recall. Patients may call us with questions and we want to send the message that there is no reason to panic. The number of reported issues with the reader is very low. This does not affect any of the sensors and anyone using the Libre mobile apps with their sensors. I actually really prefer the mobile app because of its ability to have loved ones follow the data and how easy it is to instantly connect to the clinic's cloud based system in real time for remote monitoring. We are fortunate to have a program in Ohio that can even get a free smart phone to use the app for those that can't afford one,” Isaacs remarked. “That being said, we have patients that use the reader, some still prefer it and it's great for people to have choices. We as HCP's have a great opportunity to promote safety by encouraging Libre users to use the correct charging cord along with keeping the device clean and dry and avoiding extreme cold and hot temperatures. If there is concern, we can provide instructions to get the mobile app or how to get a replacement reader.”

Abbott also pointed out steps are available on www.FreeStyleBattery.com provide guidance on how to properly store, charge and use a reader and its accompanying USB cable and power adapter.

“Similar to mobile phones and many other handheld electronic devices, most continuous glucose monitoring system readers or receivers use rechargeable lithium-ion batteries. While rechargeable lithium-ion batteries are generally safe when used properly, they may present a fire hazard if they are damaged or used improperly," said Abbott in their official statement. "We’ve been communicating with people who use our FreeStyle Libre family of readers since February to ensure they know how to safely store, charge and use our readers and have set up a website www.FreeStyleBattery.com where they can learn more. This notice does not impact people who do not own a reader or only use FreeStyle Libre portfolio sensors with our mobile apps.”

In her own statement to HCPLive, Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals, reiterated there are important nuances to consider when discussing the recall with patients.

"More importantly, this issue is created by use of charging cables and adaptors that are not issued with the Readers. This is a key piece of education many of us may have missed in the past: alternative cables and adaptors are not all designed to recharge lithium batteries and should not be used to charge the Libre readers," Bellini said. "Abbott has been notifying customers since February about this battery-related issue and in our practice we are sending messages through the patient portal as well as discussing with reader users during patient interactions the need to use the provided cable and charging adaptor."

References

  1. Center for Devices and Radiological Health. Abbott recalls Freestyle Libre Systems for fire and heat risk. U.S. Food and Drug Administration. https://www.fda.gov/medical-devices/medical-device-recalls/abbott-recalls-readers-used-freestyle-libre-freestyle-libre-14-day-and-freestyle-libre-2-flash. Published April 6, 2023. Accessed April 6, 2023.
  2. Campbell P. Freestyle Libre sensors cleared for integration with automated insulin delivery systems. HCP Live. https://www.hcplive.com/view/freestyle-libre-cleared-for-integration-with-automated-insulin-delivery-systems. Published March 17, 2023. Accessed April 6, 2023.
  3. Abbott Issues Safety Notification for freestyle libre® family of readers in the U.S. Abbott MediaRoom. https://abbott.mediaroom.com/Abbott-Issues-Safety-Notification-for-FreeStyle-Libre-Family-of-Readers-in-the-U-S. Published April 3, 2023. Accessed April 6, 2023.

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