The initial reporter complained of questionable thyroid results for 1 patient sample on a cobas 8000 e 801 module compared to competitor methods.The initial results from the customer's e 801 were reported outside of the laboratory.The competitor methods were considered correct.There were discrepant results for elecsys ft3 iii, elecsys prolactin assay, elecsys estradiol assay, elecsys testosterone ii assay from the customer's e 801 module compared the siemens centaur method.There were discrepant results for elecsys tsh assay from the customer's e 801 module compared to the siemens centaur and beckman methods.There were discrepant results for roche diagnostics cobas elecsys anti-tpo from the customer's e 801 module compared to the beckman method.There were discrepant results for elecsys dhea-s from the customer's e 801 module compared to the siemens immulite 2000 method.This medwatch will cover anti-tpo.Refer to medwatch with patient identifier (b)(6) for information on the tsh results, medwatch with patient identifier (b)(6) for information on the prolactin results, medwatch with patient identifier (b)(6) for information on the estradiol results, medwatch with patient identifier (b)(6) for information on the testosterone results, medwatch with patient identifier (b)(6) for information on the ft3 iii results, and medwatch with patient identifier (b)(6) for information on the dhea-s results.Refer to the attachment to the medwatch for all patient data.The customer's cobas e 602 module serial number was not provided.
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One patient sample was returned for investigation.The investigation identified an interfering factor against the streptavidin component of the reagent in the sample.The interfering factor is documented in product labeling which states: interference in the method sheets of all applicable products: 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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