Prodigy AutoCode Manual Del Propietário página 48

Prodigy
Talking Meter Owner's Manual
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 < 50mg/dL to over 400 mg/dL.
Example 1
If 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 70mg/dL or in the
range of 55mg/dL to 85mg/dL
If meter A produces a measurement of 60mg/dL and meter
B measures 80 mg/dL, then both are in the acceptable
range and meet the accuracy requirement.
Each manufacturer has met the System Accuracy
requirement as part of its testing to be cleared for
marketing. In the System Accuracy testing a distribution
of blood glucose readings will result at the various glucose
concentration levels for one manufacturer's system.
This is the same for other manufacturer's system.
Because of the range of acceptable readings for the
accuracy requirement, identical readings from two different
meters on the same blood sample may not happen.
Prodigy Diabetes Care, LLC www.prodigymeter.com
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