SEVEN PLUS User’s Guide | 121
Figure 4. Example of “Poor” SEVEN PLUS Performance
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:
Table 12. Summary of Irritation Events
Symptoms Reported
% of Patient Reported Events at the
Sensor Insertion Sites
Redness (Erythema) 6%
Swelling (Edema) 1%
Bruising 1%
Infection 0%
YYY
YSI Reading
•••
SEVEN PLUS Glucose Reading
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