The customer received questionable thyroid results for one patient which did not fit the clinical status of the patient and alleged there were patient-specific interfering factors.The customer used cobas e602 serial number (b)(4).Refer to the attachment to the medwatch for all patient data.Of the data provided, only the results for the elecsys tsh assay, anti-tpo, and anti-tshr assays were a reportable malfunction.Refer to the medwatch with (b)(6) for the other assays involved in the complaint.The results were reported outside the laboratory and the physician did not believe the results.Due to the elevated tsh, ft4 and ft3 results, the doctor assumed a pituitary gland issue which has not yet been analyzed or officially diagnosed.The patient was not adversely affected.Sample drawn from the patient on (b)(6) 2016 was submitted for investigation and an interfering factor to streptavidin was found in the sample.This interfering factor caused the different values for the ft4 and ft3 assays and is documented in product labeling.Review of the provided calibration and qc results did not indicate a reagent issue.
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