Accuracy Of Meter Measurements - Prodigy Autocode Owner's Manual

PRODIGY Blood Glucose Meters
®
If your test result is lower than 70 mg/dL or "Lo"
appears on your meter screen, this could be a result
of hypoglycemia. Although this result could be due to
a testing error, it is best to treat first and retest later.
Contact your healthcare professional immediately.
See Figure 99.
High Blood Glucose Test Results
If your test result is higher than 180 mg/dL, this could be a result of
hyperglycemia. If you are uncertain about this test result, retest. If the
result continues to be higher than 180 mg/dL, contact your healthcare
professional immediately.
If "Hi" appears on your meter screen, this could be a result
of severe hyperglycemia (results higher than 600 mg/dL).
Retest your blood glucose. If "Hi" appears again, contact
your healthcare professional immediately. See Figure 100.
Repeated Unexpected Test Results
If you continue to get unexpected test results, check your
blood glucose monitoring system by performing a control solution test.
Refer to "Performing a Control Solution Test" section in this manaul.
Unusual Red Blood Cell Count
A hematocrit range (percentage of red blood cells in the blood) that is
extremely high (above 55%) or low (below 30%) can also cause false
readings.
Prodigy Diabetes Care, LLC
Owner's Manual
Figure 99
Figure 100
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PRODIGY Blood Glucose Meters
®

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
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).
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
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