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Freestyle Libre 2 Manual Del Usuario página 152

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ART46983-001_rev-A 24-Aug-2022 2:30pm
Glucose Reading Availability
The System is designed to show a Sensor glucose reading after each scan that is performed throughout
the wear period after the start-up time. Tables 8a and 8b show the glucose reading capture rate for
each day of the wear duration.
Table B-8a: Glucose Reading Capture Rate Over Wear Duration (Adult; n=146)
Table B-8b: Glucose Reading Capture Rate Over Wear Duration (Pediatric; n=139)
Precision
Precision of the System was evaluated by comparing the results from two separate Sensors worn on the
same subject at the same time. Table B-9a provides data from 146 subjects in the Adult study; Table B-
9b provides data from 137 subjects in the Pediatric study. For adults, the paired absolute relative
di!erence (PARD) between the two Sensors was 8.2% with mean coe"cient of variation (CV) of 5.8%. For
children ages 4-5, PARD was 6.9% with mean CV of 4.9%. For children ages 6-17, PARD was 8.0% with CV
of 5.7%. Paired absolute di!erence (PAD) is a measurement of absolute di!erence (in mg/dL) between
paired CGM readings, while PARD is the absolute relative di!erence (in %) between paired CGM
readings.
Table B-9a: Overall between Sensor Precision (Adult; n=146)
Table B-9b: Overall between Sensor Precision (Pediatric; n=137)
Adverse Events
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 (10 out of 146 or 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

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46983-001