The initial reporter stated they received discrepant results for one patient sample tested with the elecsys tsh assay, elecsys ft3 iii, and the elecsys ft4 iii assay on a cobas 8000 e 801 module and a second e 801 analyzer used for investigation.The values measured at the customer site were reported outside of the laboratory to a physician.This medwatch will apply to the tsh assay.Please refer to the medwatch with patient identifier (b)(6).For information related to the ft3 assay and refer to the medwatch with patient identifier (b)(6) for information related to the ft4 assay.The sample was initially tested on the customer's e 801 analyzer on (b)(6) 2019.The sample was repeated on an abbott architect analyzer.The sample was also provided for investigation, where it was tested on a second e 801 analyzer.The serial number of the customer's e 801 analyzer is (b)(4).The serial number of the e 801 analyzer used for investigation is (b)(4).Tsh reagent lot number 416233, with an expiration date of october 2020 was used on this analyzer.
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A sample was returned for investigation.The investigation reproduced the tsh result obtained by the customer.The investigation was unable to find an interferent in the sample.The observed differences in tsh values generated with the roche assay and architect assay are most likely caused by differences in the overall setups of the assays, the antibodies used, differences in reference materials, and the differences in the standardization methodology used.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings.The investigation did not identify a product problem.
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