OmniPod CAT45E Guide De L'utilisateur page 164

System Accuracy According International Standard ISO 15197:2013
Capillary blood glucose results were compared with those obtained using the YSI Glucose Analyser.
System accuracy for finger samples with YSI glucose results lower than 100 mg/dL (5.55 mmol/L).
Within
± 5 mg/dL (0.3 mmol/L)
141/201 (70.1%)
System accuracy for finger samples with YSI glucose results of 100 mg/dL (5.55 mmol/L) or higher.
Within
± 5%
323/483 (66.9%)
System accuracy results for glucose concentrations between 40 mg/dL (2.22 mmol/L) and 500 mg/dL (27.8 mmol/L).
Within
± 15mg/dL (0.83 mmol/L) or ± 15%
677/684 (99.0%)
A study* evaluating glucose values from fingertip capillary blood samples obtained by 590 lay persons showed the
following results:
98.1% within ±15 mg/dL (0.83 mmol/L) of the YSI reference at glucose concentrations below 100 mg/dL (5.55
mmol/L), and 98.4% within ±15% of the YSI reference at glucose concentrations at or above 100 mg/dL (5.55
mmol/L).
*Data on file at Insulet Corporation
Within
± 10 mg/dL (0.6 mmol/L)
192/201 (95.5%)
Within
± 10%
440/483 (91.1%)
Appendix
Within
± 15 mg/dL (0.8 mmol/L)
200/201 (99.5%)
Within
± 15%
477/483 (98.8%)
151