This event occurred in (b)(6).The customer's calibration and qc data were requested but not provided.A general reagent issue can be excluded.The observed differences in ft4 values generated with the roche assay, siemens centaur assay, and abbott architect 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.Per labeling, "for diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings." 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 questionable elecsys ft3 iii and elecsys ft4 iii assay results for one patient tested on a cobas 8000 e 801 module serial number (b)(4).The customer reported out the results to a physician who asked for re-measurement of the sample.The patient¿s sample was submitted for investigation and was tested on an e 801 module, siemens centaur analyzer, and an abbott architect.This medwatch is for ft4.Refer to the medwatch with a1 patient identifier (b)(6) for the ft3 assay.
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