The customer questioned thyroid results for 2 samples from 1 patient tested on a cobas 6000 e 601 module.Both samples from the patient were submitted for investigation where discrepant results were identified for elecsys ft4 ii assay (ft4 ii), elecsys ft4 iii and elecsys anti-tshr immunoassay (anti-tshr) between the customer's e601 module, a cobas 8000 e 602 module used at the investigation site and the yamasa method.The initial results from the customer site were reported outside of the laboratory.This medwatch will cover ft4 ii.Refer to medwatch with patient identifier (b)(6) for information on the ft4 iii erroneous results and medwatch with patient identifier (b)(6) for information on the anti-tshr erroneous results.There was no allegation that an adverse event occurred.The serial number for the customer's e601 module 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 288197 with an expiration date of dec-2018.Calibration and qc data at the investigation site was acceptable.There was not enough sample material remaining to complete the investigation.Based on the data provided, a general reagent issue can be excluded.The investigation was unable to find a definitive root cause.
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