The initial reporter complained of discrepant high results for 1 patient sample tested for elecsys t3 (t3), elecsys t4 assay (t4), roche elecsys anti-tg (anti-tg) and roche diagnostics cobas elecsys anti-tpo (anti-tpo) on 2 cobas e801 modules and a cobas 6000 e 601 module compared to an immusystem analyzer and an abbott analyzer.This medwatch will cover anti-tpo.Refer to medwatch with patient identifier (b)(6) for information on the t3 results, medwatch with patient identifier (b)(6) for information on the t4 results and medwatch with patient identifier (b)(6) for information on the anti-tg results.Refer to attached data for the patient results.Questionable results were reported outside of the laboratory.The customer¿s e801 module serial number was (b)(4).The serial numbers for the e601 module and the e801 module used at the different laboratories were not provided.The reagent lot numbers used with the e601 module and the e801 module used at the other laboratories were not provided.
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The sample was submitted for investigation.The results generated at the customer site for both the e801 and e601 modules were reproduced during the investigation.Upon investigation of the patient sample, an interferent against the streptavidin component of the reagent was confirmed.This caused the high results for t4, t3, anti-tpo and anti-tg as well as the different results between the e801 module and the e601 modules.Product labeling states: "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.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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