The initial reporter stated that they received discrepant results for a total of 11 patient samples tested with the elecsys tsh assay, elecsys ft3 iii, and the elecsys ft4 iii assay on a cobas 8000 e 801 module.It was asked, but it is not known if any incorrect values were reported outside of the laboratory.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 samples were initially tested on the reporter's e 801 analyzer on (b)(6) 2019.The samples were repeated on a centuar analyzer.The samples were also provided for investigation where they were tested using a cobas 6000 e 601 module and a cobas e 411 immunoassay analyzer on (b)(6) 2019 and a second e 801 analyzer on (b)(6) 2019.No adverse events were alleged to have occurred with the patient.The serial number of the e 801 analyzer used for investigation is (b)(4).Tsh reagent lot number 386646, with an expiration date of 31-may-2020 was used on this analyzer.The serial number of the e 601 analyzer used for investigation is (b)(4).Tsh reagent lot number 373386, with an expiration date of 30-jun-2019 was used on this analyzer.The serial number of the e 411 analyzer used for investigation is (b)(4).Tsh reagent lot number 373386, with an expiration date of 30-jun-2019 was used on this analyzer.
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The investigation determined the following for samples (b)(6).Assays from different vendors can generate different values.This is related to the overall setups of the assays, the antibodies used, differences in reference materials/methods, and differences in the standardization methodology used.The investigation determined the following for samples (b)(6).The investigation could not identify a product problem.The cause of the event could not be determined.The investigation determined the following for sample (b)(6).Further investigations of the patient sample determined that it contained an interferent to a component of the ft3 assay.This limitation is covered in product labeling.
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