Important Safety Information

The information contained herein is available within the Libre 2 Flash Glucose Monitoring System user manual. Please read the User Manual prior to use.

Libre 2 Flash Glucose Monitoring System

Indications for Use

The FreeStyle Libre 2 Flash Glucose Monitoring System Reader (“Reader”) when used with a FreeStyle Libre 2 Plus Flash Glucose Monitoring System Sensor (“Sensor”) is indicated for measuring interstitial fluid glucose levels in people (age 2 and older) with diabetes mellitus, including pregnant women. The Reader and Sensor are designed to replace blood glucose testing in the self-management of diabetes, including dosing of insulin. The indication for children (age 2 - 12) is limited to those who are supervised by a caregiver who is at least 18 years of age. The caregiver is responsible for managing or assisting the child to manage the Reader and Sensor and also for interpreting or assisting the child to interpret Sensor glucose readings.

Contraindications

The Libre 2 Plus Flash Glucose Monitoring System must be removed prior to Magnetic Resonance Imaging (MRI).

Warnings:

The Libre 2 Plus Flash Glucose Monitoring System contains small parts that may be dangerous if swallowed.

Cautions:


• On rare occasions, you may get inaccurate Sensor glucose readings. If you believe your readings are not correct or are inconsistent with how you and check to make sure your Sensor has not come loose. If the problem continues or your Sensor is coming loose, remove the current Sensor and apply a new one.
• Intense exercise may cause your Sensor to loosen due to sweat or movement of the Sensor. If your Sensor comes loose, you may get no readings or unreliable readings, which may not match how you feel. Follow the instructions to select an appropriate application site.
• Do not reuse Sensors. The Sensor and Sensor Applicator are designed for single use. Reuse may result in no glucose readings and infection. Not suitable for re-sterilisation. Further exposure to irradiation may cause inaccurate results.
• The Sensor Pack and Sensor Applicator are packaged as a set and have the same Sensor code. Check that the Sensor codes match before using your Sensor Pack and Sensor Applicator. Sensor Packs and Sensor Applicators with the same Sensor code should be used together or your Sensor glucose readings may be incorrect.
• Some individuals may be sensitive to the adhesive that keeps the Sensor attached to the skin. If you notice significant irritation around or under your Sensor, remove the Sensor and stop using the Libre 2 Plus system. Contact your health care professional before continuing to use the Libre 2 Plus system.


ADC-117555 v2.0