The initial reporter stated that they received discrepant results for one patient sample tested with elecsys ft3 iii, the elecsys ft4 iii assay, roche diagnostics cobas elecsys anti-tpo, and the elecsys anti-tshr immunoassay on a cobas 8000 e 801 module.The sample also had discrepant values when tested on a cobas e 411 immunoassay analyzer and a second e 801 analyzer used for investigation.Incorrect results from the sample were reported outside of the laboratory to a physician.This medwatch will apply to the anti-tpo assay.Please refer to the medwatch with patient identifier (b)(6) for information related to the ft4 assay, 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 anti-tshr assay.The sample was initially tested at the customer site on an e 801 analyzer.Repeat measurements for anti-tg and anti-tpo were performed on an architect analyzer.The anti-tshr measurement was repeated using the yamasa method.The sample was also provided for investigation, where it was tested using a second e 801 analyzer and an e411 analyzer.The serial number of the reporter's e 801 analyzer is (b)(4).The serial number of the e 801 analyzer used for investigation is (b)(4).Anti-tpo reagent lot number 390056, with an expiration date of september 2019 was used on this analyzer.The serial number of the e411 analyzer used for investigation is (b)(4).Anti-tpo reagent lot number 404108, with an expiration date of april 2019 was used on this analyzer.
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Further investigations of the sample could reproduce the issue observed by the customer.The sample was found to contain an interfering factor to a component of the anti-tpo assay.This limitation is covered in product labeling.Per product labeling: in rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur.These effects are minimized by suitable test design.
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