Abbott is initiating a medical device correction for certain Readers in the FreeStyle Libre family of products including FreeStyle Libre, FreeStyle Libre 14 day and FreeStyle Libre 2 Readers.

Like cell phones and many other handheld electronic devices, our Readers use lithium-ion batteries. While lithium-ion batteries are generally safe when used properly, they may present a fire hazard if they are damaged.

This notice is being communicated as a voluntary Medical Device Correction to provide information about risks associated with the lithium-ion batteries contained only in the FreeStyle Libre, FreeStyle Libre 14 day and FreeStyle Libre 2 Readers.

We have received reports from some users regarding Reader issues, including battery swelling, and in rare cases extreme overheating which may pose a fire hazard. Our investigation has determined that using a charging cable or power adapter that was not included with your Readers may increase the risk of a fire hazard.

Risk to Health

It is important that you take the actions listed below to ensure your Reader is functioning properly and to reduce the risk of minor burns or fire.

Action to be Taken by Customer

To determine if your Reader needs to be replaced, click the Reader Replacement Check button below and answer the short survey.

In order to ensure that you continue to receive important information regarding your system, please visit www.LibreView.com to create an account and connect your Reader.

Action to be Taken by Company

Abbott is updating the FreeStyle Libre 14 day and FreeStyle Libre 2 Reader User’s Manuals to include the instructions below. The updated User’s Manuals will be available soon on www.FreeStyleLibre.com through the “Support” menu.

Storing the Reader, Yellow USB Cable, and Power Adapter

• Do NOT expose the Reader, power adapter or yellow USB cable to water or other liquids.
• Store the Reader between -4 °F and 140 °F.
• Do NOT place the Reader in water or other liquids. Avoid getting dust, dirt, blood, control solution, water, bleach, or any other substance in the test strip or USB port.

Charging the Reader

• Check the Reader's USB port and make sure it is dry and free of debris.
• Check the Abbott provided power adapter and yellow USB cable to make sure they are not damaged
• Use only the Abbott provided power adapter and yellow USB cable that came with your Reader.
• Choose a location for charging where you can easily access the power adapter and quickly disconnect it to prevent the potential risk of electrical shock.
• Take care when plugging and unplugging your yellow USB cable. Do not force or bend the end of the yellow USB cable into the Reader’s USB port.

Using the Reader

• If the Reader becomes too hot to hold, immediately STOP USE and contact Customer Service about replacing your Reader, yellow USB cable, and power adapter.
• Do NOT use the Reader if you notice any signs of deterioration of the Reader (such as clouding or crazing on the display of the Reader, corroding, eroding or swelling of the plastic housing, or cracking of the plastic housing or display) or if the Reader does not turn on.
• If the Reader does not turn on after being charged or you notice a significant deterioration in battery life, contact Customer Service about replacing your Reader, yellow USB cable, and power adapter.
• If the Reader is dropped or subjected to impact and you are concerned it may be damaged, perform a Reader Test to confirm it is still working properly. See Perform a Reader Test section of the Reader User Manual for instructions.

If you have any further questions or would like to report a device fault, please visit our Frequently Asked Questions (FAQs) or call Abbott Customer Service at 1-855-632-8658, available 7 days a week from 8AM to 8PM Eastern Time excluding major holidays.

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