The customer received questionable thyroid results for two patient samples from a cobas e602 analyzer.The specific date of testing was not provided.The samples were submitted for investigation and were tested on analytical e module, cobas e411, and centaur analyzers.Of the data provided, only the results for free triiodothyronine (ft3) and free thyroxine (ft4) were discrepant.Refer to the attachment to the medwatch for all patient data.Refer to the medwatch with (b)(6) for the ft3 assay.Information concerning if any result was reported outside the laboratory was requested, but was not provided.No adverse event was reported.A specific root cause could not be identified.Additional information for further investigation was requested but was not provided.From the information provided, a general reagent issue was not suspected.Differences in values between the roche and siemens analyzers could be due to the different setups of all assays, the antibodies used and the variances in reference methods.The results of all thyroid parameters vary in function of age, gender and other population characteristics which should be taken into account when analyzing the results.
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