Dexcom G5 Mobile - 2.4 Overview of Safety Statements

Dexcom G5 Mobile System User Guide
18Indications for Use and Safety Statement
2.4 Overview of Safety Statements
This section provides a review of Safety Statements containing the same elements
described above (type of Safety Statement, an action, a statement of potential harm, and
consequences) but listed in a narrative, not boxed, format. Here you’ll learn what indications
and contraindications are and what to do to keep you safe and the system in proper working
order.
Indications and Contraindications
Indications for Use
The Dexcom G5 Mobile Continuous Glucose Monitoring System (Dexcom G5) is a glucose
monitoring system indicated for the management of diabetes in persons age 2 years and
older. The Dexcom G5 is designed to replace fingerstick blood glucose testing for diabetes
treatment decisions.
Interpretation of the Dexcom G5 results should be based on the glucose trends and several
sequential readings over time. The Dexcom G5 also aids in the detection of episodes of
hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments.
The Dexcom G5 is intended for single patient use and requires a prescription.
Important User Information
Failure to use the Dexcom G5 and its components according to the instructions for use and
all indications, contraindications, warnings, precautions, and cautions may result in you
missing a severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose)
occurrence and/or making a treatment decision that may result in injury. If your glucose
alerts and readings from your Dexcom G5 do not match your symptoms or expectations, use
a fingerstick blood glucose value from your blood glucose meter to make diabetes treatment
decisions. Seek medical attention when appropriate.
Please review the product instructions before using the Dexcom G5. Indications,
contraindications, warnings, precautions, cautions, and other important user information can
be found in the product instructions that are included with, or accompany, the Dexcom G5.
Discuss with your healthcare professional how you should use the information displayed on
the Dexcom G5 to help manage your diabetes. The product instructions contain important
information on troubleshooting the Dexcom G5 and on the performance characteristics of the
system.