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.This medwatch will apply to the ft4 assay.Please refer to the medwatch with patient identifier (b)(6) for information related to the ft3 assay and refer to the medwatch with patient identifier (b)(6) for information related to the tsh assay.Refer to the attachment for all patient data.The sample was collected on (b)(6) 2020 and was tested at the customer site either on (b)(6) 2019 or (b)(6) 2019.The customer measured the sample on the e 801 analyzer and using the wako accuraseed method.The customer also tested tsh on the e 801 analyzer after diluting the sample x2, x5, and x10.The customer also treated the sample with polyethylene glycol (peg) and tested the sample on the e 801 analyzer.The sample was repeated on an abbott architect 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 customer's e 801 analyzer is (b)(4).The e 801 analyzer used for investigation is serial number (b)(4).Ft4 reagent lot number 432844, with an expiration date of september 2020 was used on this analyzer.
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