The customer questioned results for 2 samples from 1 patient tested for elecsys tsh assay (tsh), elecsys t3 (t3), elecsys ft4 ii assay (ft4 ii), elecsys anti-tpo (anti-tpo), elecsys anti-tg (anti-tg) and elecsys anti-tshr immunoassay on a cobas 6000 e 601 module compared to the centaur and ria methods.Based on the data provided, the tsh, t3, ft4 ii, anti-tpo and anti-tshr results were discrepant.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 t3 results, medwatch with patient identifier (b)(6) for information on the ft4 ii results and medwatch with patient identifier (b)(6) for information on the anti-tshr results.It is not known if the erroneous results were reported outside of the laboratory.There was no allegation that an adverse event occurred.The customer suspects an interference affecting the results.The e601 module serial number was (b)(4).The samples were requested for investigation but could not be provided.Based on the calibration and qc data, a general reagent issue can be excluded.Since the sample could not be provided, the investigation could not be completed.The investigation did not identify a product problem.The cause of the event could not be determined.
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