The investigation could 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.This event occurred in (b)(6).(b)(4).
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The initial reporter stated they received discrepant results for one patient sample tested with the elecsys ft4 iii assay on two cobas 8000 e 801 module analyzers, a cobas 8000 e 602 module, and a cobas e 411 immunoassay analyzer.Refer to the attachment for all patient data.The sample was initially tested at the customer site on their e 801 analyzer.These values were reported outside of the laboratory to a physician.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, an e 602 analyzer, and an e 411 analyzer.The serial number of the customer's e 801 analyzer is (b)(4).The serial number of the e 602 analyzer used for investigation is (b)(4).Ft4 reagent lot number 443835, with an expiration date of 30-nov-2020 was used on this analyzer.The serial number of the e 411 analyzer used for investigation is (b)(4).Ft4 reagent lot number 443835, with an expiration date of 30-nov-2020 was used on this analyzer.The serial number of the e 801 analyzer used for investigation is (b)(4).Ft4 reagent lot number 432844, with an expiration date of 30-sep-2020 was used on this analyzer.
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