The investigation did not identify a product problem.The cause of the event could not be determined.The mathematical differences of the ft4 values generated with the analyzers from roche diagnostics and siemens centaur could be due to the overall setups of the assays, the antibodies used and, differences in reference materials/methods and the standardization methodology used.This event occurred in (b)(6).
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The initial reporter received questionable elecsys ft4 iii assay results for two patients from cobas e 801 module serial number (b)(4).The samples were sent for investigation and were tested on a centaur analyzer, cobas e602 analyzer, cobas e801 analyzer, and a cobas e411 analyzer.Refer to the attachment to the medwatch for all patient data.It was not known if any questionable result was reported outside of the laboratory.
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