Product Info

Table H-10: The number and percentage of YSI (or BGM) values collected when CGM displays ‘Below 40 mg/dL’ (LOW); Calibration every
12 hours.
CGM Readings Insertion Site CGM-YSI pairs <55 <60 <70 <80 >80 Total
LOW Abdomen Cumulative, n000000
Cumulative %0%0%0%0%0%0%
Buttocks Cumulative, n000000
Cumulative %0%0%0%0%0%0%
Table H-11: The number and percentage of YSI (or BGM) values collected when CGM displays ‘Below 40 mg/dL’ (LOW); Calibration 3 or 4
times a day.
CGM Readings Insertion Site CGM-YSI pairs <55 <60 <70 <80 >80 Total
LOW Abdomen Cumulative, n000000
Cumulative %0%0%0%0%0%0%
Buttocks Cumulative, n000000
Cumulative %0%0%0%0%0%0%
Table H-12: The number and percentage of YSI (or BGM) values collected when CGM displays ‘Above 400 mg/dL’ (HIGH); Calibration every
12 hours.
CGM Readings Insertion Site CGM-YSI pairs >340 >320 >280 >240 <240 Total
HIGH Abdomen Cumulative, n001101
Cumulative % 0% 0% 100% 100% 0% 100%
Buttocks Cumulative, n000000
Cumulative %0%0%0%0%0%0%
Table H-13. The number and percentage of YSI (or BGM) values collected when CGM displays ‘Above 400 mg/dL’ (HIGH); Calibration 3 or
4 times a day.
CGM Readings Insertion Site CGM-YSI pairs >340 >320 >280 >240 <240 Total
HIGH Abdomen Cumulative, n001101
Cumulative % 0% 0% 100% 100% 0% 100%
Buttocks Cumulative, n000000
Cumulative %0%0%0%0%0%0%
Concurrence of SG and YSI values
The following tables show the percentage of concurring SG readings with FST
reference values.
Table H-14: Overall concurrence of YSI (or BGM) values and SG readings using YSI ranges on FST Days 1, 3, and 7; Calibration every 12
hours, Abdomen
YSI
Glucose
Ranges
(mg/dL)
Percent of Matched Pairs-in Each SG Glucose Range for Each YSI Glucose Range
SG (mg/dL)
Number
of
Paired
SG-YSI
<40 ≥40-60 >60-80 >80-120 >120-16
0
>160-20
0
>200-25
0
>250-30
0
>300-35
0
>350-40
0
>400
B) ≥40-60------------
■
670G Performance Data and Technical Information
670G Performance Data and Technical Information 383