From the information provided, a general reagent issue can be excluded.Assays from different vendors can generate different values.This is related to the overall setups of the assays, the antibodies used, differences in reference materials/methods, and differences in the standardization methodology used.The investigation did not identify a product problem.The cause of the event could not be determined.This event occurred in (b)(6).
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The initial reporter stated they received discrepant results for one patient sample tested with the elecsys tsh assay, elecsys ft3 iii, and the elecsys ft4 iii assay on a cobas 8000 e 801 module and a second e 801 analyzer used for investigation.The sample also had discrepant results for the elecsys ft4 ii assay when tested on the e 801 analyzer that was used for investigation.Incorrect results were reported outside of the laboratory.This medwatch will apply to the tsh assay.Please refer to the medwatch with patient identifier (b)(6) for information related to the ft3 assay, refer to the medwatch with patient identifier (b)(6) for information related to the ft4 iii assay, and refer to the medwatch with patient identifier (b)(6) for information related to the ft4 ii assay.The sample was initially tested using the customer's e 801 analyzer and repeated using the wako accuraseed method on (b)(6) 2019.The sample was also repeated on an abbott architect analyzer.The sample was provided for investigation, where it was tested on a second e 801 analyzer on (b)(6) 2019.The customer's e 801 analyzer serial number is (b)(4).The serial number of the e 801 analyzer used for investigation is (b)(4).Tsh reagent lot number 386646, with an expiration date of may 2020 was used on this analyzer.
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