Freestyle Libre - Important Safety Information; Indications for Use; Contraindications; Warnings

Important Safety Information
Indications For Use
The FreeStyle Libre Flash Glucose Monitoring System is a continuous
glucose monitoring (CGM) device indicated for the management of
diabetes in persons age 18 and older. It is designed to replace blood
glucose testing for diabetes treatment decisions.
The System detects trends and tracks patterns aiding in the detection of
episodes of hyperglycemia and hypoglycemia, facilitating both acute and
long-term therapy adjustments. Interpretation of the System readings
should be based on the glucose trends and several sequential readings
over time. The System is intended for single patient use and requires a
prescription.
Contraindications
MRI/CT/Diathermy: The FreeStyle Libre Flash Glucose Monitoring
System must be removed prior to Magnetic Resonance Imaging
(MRI), Computed Tomography (CT) scan, or high-frequency
electrical heat (diathermy) treatment. The eect of MRI, CT scans, or
diathermy on the performance of the System has not been
evaluated. The exposure may damage the Sensor and may impact
proper function of the device which could cause incorrect readings.
WARNINGS
• Do not ignore symptoms that may be due to low or high blood
glucose: If you are experiencing symptoms that are not consistent
with your glucose readings, consult your health care professional.
• Checking Sensor glucose readings with a blood glucose meter:
Under the following conditions, Sensor glucose readings may not
be accurate and you should conduct a ngerstick test using a blood
glucose meter. You should not use Sensor glucose readings to make
a diabetes treatment decision:
• If you suspect that your reading may be inaccurate for any reason
• When you are experiencing symptoms that may be due to low or
high blood glucose
• When you are experiencing symptoms that do not match FreeStyle
Libre System readings
• During times of rapidly changing glucose (more than 2 mg/dL per
minute), when interstitial uid glucose levels as measured by the
Sensor may not accurately reect blood glucose levels
• When the Sensor glucose reading does not include a Current
Glucose number or Glucose Trend Arrow
• In order to conrm hypoglycemia or impending
hypoglycemia as reported by the Sensor
• When you see the symbol, you must check your
blood glucose with a blood glucose meter before
making any treatment decisions. Sensor readings may
not accurately reect blood glucose levels.
350
250
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82
mg
dL
2pm 6pm 10pm
Glucose Going
Low
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