The initial reporter stated they received discrepant results for one patient sample tested with ck on a cobas 8000 c702 module.The customer alleges that the results may indicate there is an interferent in the sample that reacts with the assay.The sample initially resulted in a ck value of 1026 iu/l accompanied by a data flag indicating the reaction limit was exceeded.The sample repeated with a ck value of > 34041 iu/l accompanied by a data flag.The sample was diluted x20 and repeated twice on a second analyzer, resulting in ck values of 22 iu/l and 30 iu/l.The sample was tested again without dilution on the complained analyzer, resulting in a ck value of 30 iu/l.The sample was diluted again using an unknown dilution factor and repeated on an unknown analyzer, resulting in a ck value of 30 iu/l.
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Additional results were provided for the patient: (b)(6) 2023: 26 iu/l (1:20 dilution), no results with sample clot alarm, 1026 iu/l with data flag, 32023 iu/l (1:20 dilution), 30990 iu/l (decreased sample volume dilution), 2208 iu/l, 31973 (1:20 dilution), 31092 iu/l (decreased sample volume dilution), 30912 (1:10 dilution), 30556 iu/l (decreased sample volume dilution), and 1695 iu/l.
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