Important Safety Information
Indications for Use
The FreeStyle Libre 2 Flash Glucose Monitoring System Reader (“Reader”)
when used with a FreeStyle Libre 2 Flash Glucose Monitoring System
Sensor (“Sensor”) is indicated for measuring interstitial fluid glucose levels
in people (age 4 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 4 - 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 Sensor must be removed prior to Magnetic Resonance Imaging (MRI) .
WARNING:
•
Do not ignore symptoms that may be due to low or high blood
glucose . If you have symptoms that do not match the Sensor glucose
reading or suspect that your reading may be inaccurate, check the
reading by conducting a fingerstick test using a blood glucose meter .
If you are experiencing symptoms that are not consistent with your
glucose readings, consult your health care professional .
•
The FreeStyle Libre 2 Flash Glucose Monitoring System (“System”)
contains small parts that may be dangerous if swallowed .
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