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).
|
The initial reporter stated they received discrepant thyroid test results for two samples from the same patient tested on two cobas 8000 e 602 module analyzers.Results from the following assays were affected: the elecsys tsh assay, the elecsys tsh ver.2 assay, and the elecsys ft4 iii assay.This medwatch will apply to the elecsys tsh assay.Please refer to the medwatch with patient identifier (b)(6) for information related to the elecsys tsh ver.2 assay and refer to the medwatch with patient identifier (b)(6) for information related to the elecsys ft4 iii assay.All highlighted values are discrepant.Sample 1 was tested on the customer's e 801 analyzer and an abbott architect analyzer on 22-jul-2019.Sample 2 was initially tested with the tsh v.2 and ft4 assays on the customer's e 801 analyzer on 28-sep-2020.The sample was repeated on an abbott architect analyzer and a siemens centaur analyzer.The sample was also provided for investigation where it was tested with the tsh, tsh v.2, and ft4 assays on a second e 801 analyzer on 13-oct-2020.The serial number of the customer's e 801 analyzer was requested, but not provided.Tsh reagent lot number 479739 was used on this analyzer.The serial number of the e 801 analyzer used for investigation is (b)(4).Tsh reagent lot number 454296, with an expiration date of may 2021 was used on this analyzer.
|