Discrepant results (accuracy) comparison of inratio test with lab results provided by end-user at time complaint was filed: date: 01/12/07, inratio: 6.
1, lab: 3.
6, mean: 4.
85, confidence limits: 2.
8-7.
2.
Per internal procedure, the mean of the inratio meter an comparative system inr were calculated.
Both inratio and lab values are within the confidence limits for inr testing.
The results are not considered discrepant within the context of the documented variability for inr testing.
Therefore, further testing is not required at this time.
Ts updated this case on 01/18/2007.
Inratio precision data provided by end-user lot 060452: 01/17/07 first inr = 7.
5(old strip).
Second test inr = 5.
5 (new strip), mean = 6.
5; sd = 1.
4; %cv = 21.
7%.
The %cv is grater than 20%.
Per internal procedure, the precision failed the criteria for precision.
Products will be tested.
Ts updated this case on 01/19/2007.
Discrepant results (accuracy) comparison of inratio test with lab results provided by end-user at time complaint was filed: date: 01/19/07, inratio: 6.
5, lab: 4.
0, mean: 5.
25, confidence limits: cannot be determined.
Per internal procedure, the mean of the inratio meter and comparative system inr were calculated.
The confidence limits for inr testing cannot be determined.
The mean was > 5.
0 and the difference between inr's >2.
2.
The comparison was considered inaccurate.
Products will be tested.
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Caller alleged discrepant results compared with the lab.
Results as follows: date: 01/12/07, inratio: 6.
1, lab: 3.
6.
Ts updated this case on 01/18/2007 and 01/19/2007.
01/17/07, first test inr = 7.
5(old strip).
Second test inr = 5.
5(new strip).
Date: 01/19/07, inratio: 6.
5, lab: 4.
0.
Caller has antiphospholipid antibody syndrome and recently had an episode of multi organ infection resulting in failure of adrenal glands.
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