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Prodigy Diabetes Care, LLC 1.800.243.2636
Prodigy Meter Owner’s Manual
FAQ: Can two (2) blood glucose meters (produced by different
manufacturers) produce readings that are not the same from the
same blood sample? Does this make one reading more accurate
than the other?
Answer: Yes, different meters can produce results that are not the
same using the same blood sample. No, this does not mean that
one result is more accurate than the other.
The reasons for this are as follows:
1. All blood glucose meters have to meet the requirements
of published standards issued by ISO (International Standards
Organization) and CLSI (Clinical and Laboratory Standards
Institute). The primary standard is ISO 15197: In Vitro
Diagnostic Test Systems-Requirements for Blood Glucose
Monitoring Systems for Self Testing in Managing Diabetes
Mellitus. The ISO standard references CLSI standards for
specific tests.
2. The accuracy requirements for the blood glucose monitoring
system—meters and test strips—as stated in ISO 15197
is this:
Ninety five percent (95%) of the individual glucose results
shall fall within ±15 mg/dL ( 0.83 mmol/L) of the results
of the manufacturer’s measurement procedure at glucose
concentrations <75 mg/dL (<4.2 mmol/L) and within ± 20% at
glucose concentrations ≥ 75 mg/dL ( ≥ 4.2 mmol/L).
Accuracy of Meter Measurements
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