No device related serious adverse events occurred during the studies. In the Adult study, mild skin irritations, such as erythema, bruising, bleeding, and scabbing were reported around the insertion site and adhesive area by a small number of subjects (6.8%).
Pain was mostly reported as none with only one instance of mild pain. In the Pediatric study, there were 8 instances of erythema (4 "well-defined redness", and 4 "slight pink"), 5 instances of edema (3 slight edema, 2 slight edema with defined edges), 2 instances of mild bleeding, one instance of mild induration and one instance of mild rash1.
1 FreeStyle Libre 2 User's Manual.