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).
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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.The sample was initially tested on the customer's e 801 analyzer on (b)(6) 2020 and these values were reported outside of the laboratory to a physician.The customer repeated testing using the wako accuraseed ft4 method.The customer also treated the sample with polyethylene glycol (peg) and repeated on the e 801 analyzer.The sample was provided for investigation, where it was tested on a second e 801 analyzer on (b)(6) 2020.The sample was repeated again on an abbott architect analyzer.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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