This event occurred in (b)(6).Based on the data provided, a general reagent issue can be excluded.Assays from different vendors can generate different values.This relates to the overall setups of the assays, the antibodies used and, differences in reference materials/methods and 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 questionable elecsys ft4 iii assay results for 1 patient sample on a cobas e 801 module, serial number (b)(4).This medwatch covers the alleged results for the ft4 assay.Please refer to medwatch mdr-47373 for the alleged ft3 assay results.See highlighted section of attachment "cn548999.Pdf" for patient results.The results were reported to the patient's physician, who requested the sample test be repeated.
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