Risks And Benefits; Sensor Insertion Risks; Chapter 3: Risks And Benefits - Dexcom G6 Pro User Manual

Chapter 3: Risks and Benefits

When using any medical device, there are risks and benefits. In this
chapter, you'll learn what they are.
3.1 Risks
The risks with using G6 Pro are:
• Sensor insertion issues
• Local skin irritation from adhesive patch
• Additional risks of using the G6 Pro app are:
• Not getting alarm/alerts
• Your patient using G6 Pro to make treatment decisions when
they shouldn't
This section covers each of those risks in detail.
Follow system instructions. If not, your patient could have a severe low
or high glucose event.

Sensor Insertion Risks

There is a remote chance a sensor wire could break or detach and
remain under the skin. Sterile broken or detached sensor wires usually
don't pose a significant medical risk. It's uncommon, but inserting
the sensor can cause infection, bleeding, or pain. Only a few patients
in the clinical studies got slight redness and swelling. If a sensor wire
breaks off or detaches and remains under the skin, the user should
contact an HCP and Technical Support:
• TechSupport@dexcom.com
• General: 1.844.607.8398, 24/7
• Professionals Toll Free: 1.844.436.2271,
6 am–6 pm (PST), Monday–Friday
• Professionals Toll Call: 1.858.200.0200,
6 am–6 pm (PST), Monday–Friday
G6 Pro User Guide
Chapter 3: Risks and Benefits
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