Important Safety Information; Indications For Use; Contraindications; Warnings - Freestyle Libre User Manual

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 effect 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 .
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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 fingerstick 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 fluid glucose levels as measured by the
Sensor may not accurately reflect blood glucose levels
• When the Sensor glucose reading does not include a Current
Glucose number or Glucose Trend Arrow
• In order to confirm 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 reflect blood glucose levels .
Glucose Going
Low
82
mg
dL
350
250
150
50
2pm 6pm 10pm
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