REPORT EXTERNAL QUALITY CONTROL COAGUCHEK XS
Institution :
City :
Stichting ECAT
Voorschoten
Date of control :
Monitor :
Serial no. :
Lot nr. teststrips :
Batch no QC set :
02/01/2014
Reference Monitor
UP 00112233
510
B221B00
Test results
Sample
Target
%U1
Target Range
Measured
%D
Conclusion
1
2.0
0.6
1.7 - 2.3
1.9
-5.0
OK
2
2.8
0.8
2.4 - 3.2
2.7
-3.6
OK
3
3.6
0.8
3.0 - 4.1
3.4
-5.6
OK
4
4.4
1.3
3.7 - 5.1
4.4
0.0
OK
Acceptance range
Measured
Conclusion
> 0.950
0.995
OK
Slope :
0.80 - 1.20
1.03
OK
Intercept :
-0.50 - 0.50
-0.18
OK
4
4
OK
1) Relative uncertainty of the target value.
Evaluation
Correlation :
Correct QC results :
Percentage Deviation
Correlation Target and Measured value
4.0
Deviation (%)
Measured INR
5.0
3.0
2.0
1.0
1.0
2.0
3.0
4.0
5.0
25
20
15
10
5
0
-5
-10
-15
-20
-25
1.0
2.0
Target INR
3.0
4.0
5.0
INR target value
FINAL CONCLUSION
This CoaguChek XS monitor pass the ECAT criteria for quality control:
REMARKS
YES
Signature + Date:
7 maart 2014
Dr. P. Meijer
Director ECAT Foundation
ECAT Foundation
P.O. Box 107
2254 AG Voorschoten
The Netherlands
T. +31 71 3030910
E. [email protected]
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