Based on the information provided, a general reagent issue can be excluded.The investigation did not identify a product problem.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.Medwatch field udi number = (b)(4).This event occurred in (b)(6).
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The initial reporter stated they received discrepant thyroid test results for two patient samples tested on two cobas 8000 e 801 modules, a cobas 8000 e 602 module, and a cobas e 411 immunoassay analyzer.Results from the following assays were affected: the elecsys tsh assay, the elecsys tsh assay ver.2, and the elecsys ft4 iii assay.The values measured at the customer site were reported outside of the laboratory to a physician.This medwatch will apply to the ft4 assay.Please refer to the medwatch with patient identifier (b)(6) for information related to tsh, and refer to the medwatch with patient identifier (b)(6) for information related to the tsh ver.2 assay.Refer to the attachment for all patient data.The values highlighted in yellow were questioned.The samples were initially tested on the customer's e 801 analyzer on (b)(6)2021.The samples were repeated on a siemens centaur analyzer.The samples were also provided for investigation, where they were tested on the second e 801 analyzer and an e411 analyzer on (b)(6) 2021 and on an e 602 analyzer on (b)(6) 2021.The serial number of the customer's e 801 analyzer is (b)(4).The ft4 reagent lot number and expiration date used on this analyzer were requested, but not provided.The serial number of the e 801 analyzer used for investigation is (b)(4).Ft4 reagent lot number 483198, with an expiration date of 30-jun-2021 was used on this analyzer.The serial number of the e411 analyzer used for investigation is (b)(4).Ft4 reagent lot number 478085, with an expiration date of 31-may-2021 was used on this analyzer.The serial number of the e 602 analyzer used for investigation is (b)(4).Ft4 reagent lot number 478085, with an expiration date of 31-may-2021 was used on this analyzer.
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