Owner`s manual

PRODIGY AutoCode® Blood Glucose Meter PRODIGY AutoCode® Blood Glucose Meter
Owner’s Manual Owner’s Manual
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Accuracy of Meter Measurements
FAQ: Can two (2) blood glucose meters produce
different readings that are from the same blood
sample? Does this make one reading more
accurate than the other?
Answer: Yes, different meters can produce
different readings using the same blood
sample.
No, this does not necessarily mean that
one result is more accurate than the
other.
The reasons for this are as follows:
1. The FDA recognized standard for glucose
meter accuracy is ISO 15197: In Vitro
Diagnostic Test Systems Requirements
for Blood Glucose Monitoring Systems for
Self Testing in Managing Diabetes Mellitus.
This standard sets accuracy requirements
that manufacturers must meet before being
approved by the FDA to market their
glucose meters.
2. The accuracy requirements for the blood
glucose monitoring system—meters and test
strips—as stated in ISO 15197 are:
Ninety-ve 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).
How does this answer the FAQ
The accuracy of the system is determined by a
clinical study using 100 blood samples at interval
glucose concentrations ranging from < 50 mg/
dL to over 400 mg/dL measured using both
the manufacturer’s meter and a clinical blood
glucose analyzer for comparison (reference
measurement).
Example
I f the manufacturer’s reference measurement is 70
mg/dL this means that the meter measurements
are considered accurate if they fall within ± 15 mg/
dL of 70 mg/dL (from 55 mg/dL to 85 mg/dL).
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