Beurer GL 42 (mg/dL) - Manual (Page 29)

Beurer GL42 mg/dL 29
Results of the intermediate precision measurement
Sample Control material
(mg/dL)
Grand mean
value (mg/dL)
Pooled standard
deviation
Pooled coefficient
of variation (%)
1 46.2 43.8 2.2 5.1
2 135.0 131.7 3.7 2.8
3 350.0 346.3 8.5 2.4
System accuracy
The GL42 blood glucose monitor in comparison with the YSI.
Three lots of GL42 blood glucose test strips have been tested to assess the system accuracy of the
GL42 blood glucose measuring system and to compare it with the reference method in which capil-
lary whole blood concentrations of 24.8 to 715 mg/dL have been used.
Result of the system accuracy for glucose concentrations <100 mg/dL (<5.55 mmol/L)
Within ±5 mg/dL
(Within ±0.28 mmol/L)
Within ±10 mg/dL
(Within ±0.56 mmol/L)
Within ±15 mg/dL
(Within ±0.83 mmol/L)
116/186 (62.4%) 172/186 (92.5%) 184/186 (98.9%)
Results of the system accuracy for glucose concentrations ≥100 mg/dL (≥5.55 mmol/L)
Within ±5% Within ±10% Within ±15%
250/414 (60.4%) 379/414 (91.5%) 413/414 (99.8%)
Results of the system accuracy for combined glucose concentrations between 24.8 mg/dL
(1.4 mmol/L) and 715 mg/dL (39.7 mmol/L).
Within ±15 mg/dL or ±15%
(Within ±0.83 mmol/L or ±15%)
597/600 (99.5%)
In comparison to the YSI, the GL42 met the EN ISO 15197:2013 standard, whereby 95% of the blood
glucose values measured have to fall within the following zones: either ±0.83 mmol/L (±15 mg/dL) of
the measured average value when using the reference measuring procedure for blood glucose con-
centrations <100 mg/dL (<5.55 mmol/L) or ±15% for blood glucose concentrations of ≥100 mg/dL
(≥5.55 mmol/L). 99% of the individual measured blood glucose values must fall within zones A and
B of the Consensus Error Grid (CEG) for diabetes type 1.