This event occurred in (b)(6).Customer calibration and qc data were requested but not provided.The observed differences in ft4 values generated with the roche assay and siemens centaur assay are most likely caused by differences in the overall setups of the assays, the antibodies used, differences in reference materials, and the differences in the standardization methodology used.The investigation did not identify a product problem.The cause of the event could not be determined.
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The initial reporter received a questionable high elecsys ft4 iii result for one patient from a cobas 8000 e 801 module, serial number (b)(4).The questionable result was reported outside the laboratory.The physician requested further testing for confirmation.The patients sample was sent for investigation and was tested on a cobas 8000 e 801 module, cobas 8000 e 602 module, and a cobas e 411 immunoassay analyzer.The patients sample was also outsourced and tested on a centaur analyzer.Refer to the attachment to the medwatch for all patient data.
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