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| 1 | 2005
Klinisk Biokemi i Norden
over-estimated when hematocrit was low and
under-estimated when hematocrit was high. The
hematocrit effect applies not only for high glu-
cose values in combination with high hematocrit
values, as described in the package insert, but is
also true for glucose values below 11,1 mmol/L
and for hematocrit values within the reference
range. Although affected by hematocrit, the
results achieved under standardised and optimal
conditions were within ±15 % of the comparison
method.
- The diabetic patients summarised the Ascensia
Contour device as easy to use. As a whole they
were pleased with the device. The patients that
had used the user manual were satisfied with the
manual.
Conclusion
Glucose measurements on Ascensia Contour have
acceptable precision. The results obtained under
optimal measuring conditions are within the strict
quality goals for total error set by ADA. The measu-
rements performed by the diabetic patients initially,
when the device was new, are within the quality
goals set in the ISO-guide 15197. After having been
used at home and outside controlled conditions
for three weeks, the device no longer performed
satisfactorily. The results obtained after the prac-
tice period do no longer fulfil the quality goals.
It has not been possible to find an explanation
for this, but there is no reason to believe that the
poor results are caused by user errors. The glucose
results in this evaluation are affected by hematocrit
in a higher degree than described in the package
insert. The users conclude that the Ascensia Contour
device is easy to use and they are quite satisfied
with the device.
Comments from Bayer Diagnostics
A rebuttal to SKUP from Bayer HealthCare Self
Testing Systems Division is found as an attachment
to the report. The comments from Bayer are follo-
wed by an answer from SKUP.
The complete evaluation report is available at www.
skup.nu and is recommended to get further insight
in the complexity of the findings in this evalua-
tion.
Äppelblom. Foto: Henrik Alfthan.
