The investigation could not identify a product problem.The cause of the event could not be determined.Assays from different vendors can generate different values.This relates to the overall setups of the assays, the antibodies used, differences in reference materials/methods, and differences in the standardization methodology used.This event occurred in (b)(6).(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.No incorrect results were reported outside of the laboratory.This medwatch will apply to the ft4 assay.Please refer to the medwatch with patient identifier (b)(6) for information related to the tsh assay and refer to the medwatch with patient identifier (b)(6) for information related to the ft3 assay.Refer to the attachment for all patient data.The sample was initially tested at the customer site on their e 801 analyzer on (b)(6) 2020.The sample was repeated on a siemens centaur analyzer.The sample was also provided for investigation, where it was tested on a second e 801 analyzer on (b)(6) 2020.The serial number of the e 801 analyzer used at the customer site is (b)(4).The serial number of the e 801 analyzer used for investigation is (b)(4).Ft4 reagent lot number 432844, with an expiration date of september 2020 was used on this analyzer.
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