Unique identifier (udi): (b)(4) a general reagent issue can be excluded.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.The investigation did not identify a product problem.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 a cobas 6000 e 601 module and a cobas 8000 e 602 module.The sample was initially tested on the customer's e 601 analyzer on (b)(6) 2021, resulting with a ft4 value of 1.84 pg/ml.This initial value was reported outside of the laboratory to a physician.The sample was repeated on a siemens centaur analyzer, resulting with a value of 1.51 pg/ml.The sample was also provided for investigation, where it was tested on an e 602 analyzer on (b)(6) 2021, resulting with a value of 1.69 ng/dl.The serial number of the customer's e 601 analyzer was requested, but not provided.The ft4 reagent lot number and expiration date used on this analyzer was requested, but not provided.The serial number of the e 602 analyzer used for investigation is (b)(4).Ft4 reagent lot number 478085, with an expiration date of may 2021 was used on this analyzer.
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