The initial reporter stated they received discrepant results for one patient sample tested with elecsys ft3 iii, the elecsys ft4 iii assay, and the elecsys tsh assay on a cobas 8000 e 801 module and a second e 801 analyzer used for investigation.Incorrect results from the sample were reported outside of the laboratory.This medwatch will apply to the tsh assay.Please refer to the medwatch with patient identifier (b)(4) for information related to the ft3 assay and refer to the medwatch with patient identifier (b)(4) for information related to the ft4 assay.Refer to the attachment for all patient data.The sample was collected on (b)(6) 2019 and tested on the reporter's e 801 analyzer on (b)(6) 2019.The sample was repeated by the reporter on (b)(6) 2019 using the wako accuraseed method.The sample was repeated again on an architect analyzer.The sample was also provided for investigation where it was tested on a second e 801 analyzer on (b)(6) 2019.The serial number of the e 801 analyzer used by the reporter is (b)(4).The serial number of the e 801 analyzer used for the investigation is (b)(4).Tsh reagent lot number 386646, with an expiration date of may 2020 was used on this analyzer.
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The investigation was able to replicate the customer¿s results.A general reagent issue can be excluded.Differences in results and reference ranges from tsh assays by different manufactures, in this case abbott, can vary due to differences in the types of antibodies used, setups of the assays, and standardization methodologies.
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