Do Not Ignore Low/High Symptoms; Who Should Not Use; Calibrate On Schedule; Placement - Dexcom G5 mobile User Manual

The following warnings may result in the consequence of missing severe hypoglycemia (low
blood glucose) or hyperglycemia (high blood glucose) or making a treatment decision that
results in injury:

Do Not Ignore Low/High Symptoms

Do not ignore symptoms of low or high glucose. If your glucose alerts and readings do
not match your symptoms or expectations, you should obtain a fingerstick blood glucose
value from your blood glucose meter to make diabetes treatment decisions or seek
immediate medical attention.

Who Should Not Use

The Dexcom G5 Mobile CGM System was not evaluated or approved for the following
persons:
• Pregnant women
• Persons on dialysis
The Dexcom G5 Mobile CGM System's accuracy has not been tested in people within
these groups and the system's glucose readings may be inaccurate.

Calibrate on Schedule

Calibrate the Dexcom G5 Mobile CGM System at least once every 12 hours. The Dexcom
G5 Mobile CGM System needs to be calibrated in order to provide accurate readings.
Do not use the Dexcom G5 Mobile CGM System for diabetes treatment decisions unless
you have followed the prompts from the device and calibrated every 12 hours after the
initial calibration.

Placement

Do not insert the sensor component of the Dexcom G5 Mobile CGM System in a site
other than the belly/abdomen (ages 2 years and older) or the upper buttocks (ages 2
to 17 years). The placement and insertion of the sensor component of the Dexcom G5
Mobile CGM System is not approved for other sites. If placed in other areas, the Dexcom
G5 Mobile CGM System may not function properly.
Initial Calibration: Data/Alarm/Alert
Do not expect sensor glucose readings or alarms/alerts from the Dexcom G5 Mobile
CGM System until after the 2-hour startup. The Dexcom G5 Mobile CGM System will
NOT provide any sensor glucose readings or alarms/alerts until after the 2-hour startup
Dexcom G5 Mobile System User Guide
Indications for Use and Safety Statement 13