General Cgm System Warnings - Dexcom G5 mobile User Manual

2.5 General CGM System Warnings

Warnings
Warnings outline important hazard information, describing any serious and/or life threatening
situations, their consequences, how to avoid danger while using the system and how to
protect the Dexcom G5 Mobile CGM System from harm.
Review Training Materials
Thoroughly review the training materials included with your Dexcom G5 Mobile CGM System
before using.
Incorrect use could lead you to misunderstand system information or might affect its
performance and you might miss a severe low or high glucose event.
Treatment Decisions
The Dexcom G5 Mobile CGM System does not replace your BG meter.
When making treatment decisions, such as the amount of insulin you need, only use your
BG value. Don't use the Dexcom G5 Mobile CGM System sensor glucose readings because
readings can be different from your BG value. If sensor glucose readings are used in
determining treatments, it could result in you missing a severe low or high glucose event.
Don't Ignore Low/High Symptoms
If your sensor glucose readings don't match your symptoms, measure your BG with a
fingerstick. You may miss a severe low or high glucose event.
Who Shouldn't Use
The Dexcom G5 Mobile CGM System was not evaluated for the following persons:
• Pregnant women
• Persons on dialysis
Do not use the Dexcom G5 Mobile System in critically ill patients. It is not known how
different conditions or medications common to the critically ill population may affect
the performance of the system. Sensor glucose readings may be inaccurate in critically
ill patients.
The system's accuracy hasn't been tested in people falling into these groups and sensor
glucose readings may be inaccurate, resulting in missing a severe low or high event.
Dexcom G5 Mobile System User Guide
Indications for Use and Safety Statement 20