The initial reporter stated they received discrepant results for one patient sample tested with the elecsys tsh assay and elecsys ft3 iii on a cobas 8000 e 801 module.The sample also had discrepant tsh and ft3 results when tested on a cobas e 411 immunoassay analyzer, a cobas 8000 e 602 module, and a second e 801 analyzer used for investigation.The measurements obtained at the customer site were reported outside of the laboratory to a physician.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.The sample was initially tested on the customer's e 801 analyzer on (b)(6) 2020.The sample was repeated on a centaur analyzer.The sample was provided for investigation, where it was tested on the e411, e 602, and second e 801 analyzer on (b)(6) 2020.The e 801 analyzer used at the customer site is serial number (b)(4).The e 602 analyzer used for investigation is serial number (b)(4).Tsh reagent lot number 429091, with expiration date of 30-apr-2020 was used on this analyzer.The e411 analyzer used for investigation is serial number (b)(4).Tsh reagent lot number 347456, with expiration date of 01-sep-2020 was used on this analyzer.The e 801 analyzer used for investigation is serial number (b)(4).Tsh reagent lot number 416233, with expiration date of 31-oct-2020 was used on this analyzer.
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