This field safety notice is being communicated as a voluntary Medical Device Correction to provide information about the risks associated with the lithium-ion batteries contained in the FreeStyle Libre, FreeStyle Libre 14 day and the FreeStyle Libre 2 Readers. ADC has received reports from some users regarding battery issues, including battery swelling, and in rare cases extreme overheating which may pose a fire hazard. ADC’s investigation has determined that using a charging cable or power adapter that was not included with the FreeStyle Libre, FreeStyle Libre 14 day or FreeStyle Libre 2 Reader could increase the risk of a fire hazard.

FreeStyle Libre, FreeStyle Libre 14 day and FreeStyle Libre 2 Readers.

Please complete the Reader Replacement Check from the menu above.

No.  We are informing you on how to safely store, charge and use your 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.

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 the next question or Perform a Reader Test section of the Reader User’s Manual for instructions.

Touch the Settings symbol from the Home screen, select System Status and then select Reader Test. The Reader Test will perform internal diagnostics and will allow you to check that the display, sounds, and touchscreen are working properly. 

If your Reader exhibits battery swelling, extreme overheating, or significant deterioration in battery life or if your yellow USB cable or power adapter appears damaged, please immediately discontinue use and call Customer Service to request a replacement. While you are waiting for your replacement, you should use an alternate method for monitoring your glucose.

If you want to discontinue using your Reader and have a compatible Android or iOS smartphone, you can use either the FreeStyle LibreLink or FreeStyle Libre 2 App on your smartphone.  Smartphone compatibility can be checked at www.FreeStyleLibre.us/support/overview.html. Note: You can't transition an active Sensor from the Reader to the App unless you're using a FreeStyle Libre 14 day Sensor.

Absolutely.  The safety of our customers is our number one priority, and this is why we are informing you about this important safety information.  If you have any questions or concerns, please contact Customer Service.

No.  This is information that will be helpful to know on how to safely store, charge and use your FreeStyle Libre, FreeStyle Libre 14 day, and FreeStyle Libre 2 Readers.  We appreciate your support of FreeStyle Libre systems.