Chapter 3 | Risks And Benefits; Risks - Dexcom Pro Q User Manual

Chapter 3
When using any medical device, there are risks and benefits.

3.1 Risks

The risks with using Dexcom Pro Q are:
• Sensor insertion issues
• Interfering substance risks
This section covers each of those risks in detail.
Follow system instructions.
Sensor Insertion Risks
It's uncommon, but inserting the sensor can cause infection, bleeding, or pain, and
wearing the adhesive patch can irritate the skin. Only a few patients in the clinical
studies supporting Dexcom Pro Q got slight redness and swelling.
No sensor wires broke in the supporting clinical studies; however, there is a remote
chance a sensor wire could break or detach and remain under the skin. Sterile broken
sensor wires usually don't pose a significant medical risk. If a sensor wire breaks off or
detaches and remains under the skin, contact your HCP and Technical Support
(M – F, 6 AM – 6 PM PST):
• Toll free: 1.844.857.6319
Interfering Substance Risks
In previous generations of Dexcom CGM systems (G4/G5), acetaminophen could affect
sensor readings. However, with the Dexcom Pro Q, a participant can take a standard
or maximum acetaminophen dose of 1 gram (1,000 mg) every 6 hours. Taking higher
than the maximum dose of acetaminophen (e.g. > 1 gram every 6 hours in adults) may
affect the Dexcom Pro Q readings and make them look higher than they really are.
Dexcom Pro Q ™ System User Guide
Chapter 3: Risks and Benefits
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Risks and Benefits
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