Important Safety Information
Important Safety
Information
Indications For Use
The FreeStyle Libre 14 day 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 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.
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.
•
Check Sensor glucose readings by conducting a fingerstick test with a blood glucose meter under the following conditions, when Sensor glucose
readings may not be accurate and should not be used to make a diabetes treatment decision:
o
If you suspect that your reading may be inaccurate for any reason
o
When you are experiencing symptoms that may be due to low or high blood glucose
o
When you are experiencing symptoms that do not match the Sensor glucose readings
o
During the first 12 hours of wearing a FreeStyle Libre 14 day Sensor
o
During times of rapidly changing glucose (more than 2 mg/dL per minute)
o
When the Sensor glucose reading does not include a Current Glucose number or Glucose Trend Arrow
o
In order to confirm hypoglycemia or impending hypoglycemia as reported by the Sensor
o
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.
o
If you are using the FreeStyle LibreLink app, you must also have access to a blood glucose monitoring system as the App does not provide one.
•
Hypoglycemic unawareness:
The System has not been evaluated for use in patients with hypoglycemic unawareness and will not automatically alert you
of a hypoglycemic event without you scanning your Sensor.
•
No alarms without a Sensor scan:
The System does not have alarms that will automatically notify you when you are having a severe low (hypoglycemic)
or high (hyperglycemic) glucose event unless you scan your Sensor. For example, the System does not have an alarm that can alert or wake you when
you are sleeping in the case of low or high glucose.
•
Choking hazard:
The System contains small parts that may be dangerous if swallowed.
