The initial reporter stated they received discrepant results for 9 samples from the same patient tested with thyroid assays on the cobas 8000 e 602 module.It is alleged that the patient was "misdiagnosed as being hyperthyroid." the following assays were affected: the elecsys tsh assay, elecsys ft3 iii, the elecsys ft4 assay, and roche diagnostics cobas elecsys anti-tpo.Roche manufactures two ft4 assays, the elecsys ft4 ii assay and the elecsys ft4 iii assay.It was asked, but it is not known which specific ft4 reagent was used.This medwatch will apply to the tsh assay.Patient identifier (b)(6) for information related to the ft4 assay.Patient identifier (b)(6) for information related to the ft3 assay.Patient identifier (b)(6) for information related to the anti-tpo assay.Refer to the attachment for all patient data.No units of measure were provided for the assay results.The serial number of the e 602 analyzer is (b)(4).
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