Adverse Events - Dexcom G6 Pro User Manual

Table 11� Survey on Automated Applicator (n=76)
Question
Comfort: Painless
(mild, no pain)
Ease of use: easy
(somewhat or very)
IFU ease of use: easy
(somewhat or very)

Adverse Events

No serious adverse events (AEs) or device-related serious adverse
events occurred during the studies. There was a total of 24 mild to
moderate AEs which occurred during the studies (among 374 sensors).
13 of these AEs occurred due to either skin irritation, such as erythema
(redness) or edema (swelling), at the sensor needle insertion area or
around the adhesive area, or mild to moderate excoriation
and infection.
G6 Pro User Guide
Appendix G: Technical Information
Number of subjects
(n)
76
76
61
Percent (95% LB)
84%
100%
100%
145