The initial reporter received questionable elecsys ft4 iii assay results for one patient tested on a cobas 8000 e 801 module serial number (b)(4).The customer reported the result to a physician who asked for the re-measurement of the sample.The sample was provided for an investigation and was tested on an e 801 module, e 602 module, and an e411 immunoassay analyzer.The sample was also tested on an outsourced siemens centaur analyzer.This medwatch is for ft4.Refer to the medwatch with patient identifier (b)(6) for the ft3 assay.
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The customer's calibration and qc information were requested but not provided.The customer provided the patient's sample for an investigation.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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