The customer questioned results for 3 patients tested for elecsys ft4 iii (ft4 iii), elecsys tsh assay (tsh), elecsys ft4 ii assay (ft4 ii) and elecsys ft3 iii (ft3 iii) on a cobas 6000 e 601 module.The initial results were reported outside of the laboratory and the customer requested an investigation of the patient samples.Based on the data provided, discrepant results were identified for all 3 patients tested for ft4 iii, tsh, ft4 ii and ft3 iii between the customer's e601 module, a cobas 8000 e 602 module used at the investigation site and the abbott architect method.This medwatch will cover ft4 ii.Refer to medwatch with patient identifier (b)(6) for information on the ft4 iii results, medwatch with patient identifier (b)(6) for information on the tsh results and medwatch with patient identifier (b)(6) for information on the ft3 iii results.There was no allegation that an adverse event occurred.The customer's e601 module serial number was (b)(4).The e602 module serial number used at the investigation site was (b)(4).The ft4 ii reagent lot number used at the investigation site was 303235 with an expiration date of feb-2019.Calibration and qc data at the investigation site was ok.There was not enough sample material remaining to complete the investigation.Based on the information provided, a general reagent issue can be excluded.Assays from different manufacturers, in this case abbott can generate different results due to the overall setups of the assays, the antibodies used, and differences in reference materials and the standardization methodology used.The investigation was unable to find a definitive root cause.
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