Dexcom SEVEN PLUS User Manual page 121

Example of "Poor" SEVEN PLUS Performance
Figure 4.
YSI Reading
YYY
Adverse Events
Overall 92% of patients reported no symptoms of irritation and 8% reported at least one symptom at
any insertion site. During the trial irritation such as mild redness, mild swelling, mild bruising was seen.
Although bleeding was not seen in this study, other studies using the same sensor showed a small per-
centage of persons who had bleeding after needle insertion. See Table 12 below for the types of irritation
looked for and reported on during this trial:
Summary of Irritation Events
Table 12.
Symptoms Reported
Redness (Erythema)
Swelling (Edema)
Bruising
Infection
SEVEN PLUS Glucose Reading
•••
% of Patient Reported Events at the
Sensor Insertion Sites
6%
1%
1%
0%
SEVEN PLUS User's Guide | 121