The initial reporter received questionable elecsys ft4 iii assay, elecsys tsh assay, and elecsys ft3 iii results from the cobas e 801 module.This mdr will cover elecsys tsh assay reagent.Refer to the mdr with patient identifier = (b)(6) for the elecsys ft3 iii assay reagent and the mdr with patient identifier = (b)(6) for the elecsys ft4 iii assay reagent.It was noted that additional tsh dilution test results were: x2 diluted: 1.810 uiu/ml, x5 diluted: 2.000 uiu/ml, x10 diluted: 2.110 uiu/ml.The questionable results were reported outside the laboratory.
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The tsh values generated from all analyzers used were within the reference range of the respective methods.Differences of the tsh values generated with the different analyzers are caused by differences of the setups of the assays, the antibodies used, and differences of the standardization materials and procedures used.The investigation did not identify a product problem.The cause of the event could not be determined.
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