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The customer complained of questionable thyroid results for 4 patient samples tested on a cobas 8000 e 801 module.The patient samples were submitted for investigation.For sample 1 discrepant results were identified for elecsys ft4 iii assay between the customer's e801 module and an e801 and the centaur method used at the investigation site.For sample 2 discrepant results were identified for elecsys ft3 iii between the customer's e801 module and an e801, an e602, an e411, and the centaur method used at the investigation site.For sample 3 discrepant results were identified for elecsys ft4 iii assay between the e411 and the centaur method used at the investigation site.For sample 4 discrepant results were identified for elecsys tsh assay between the e602, an e411, and the centaur method used at the investigation site.This medwatch will cover tsh.Refer to medwatch with patient identifier (b)(6) for information on the ft4 iii results, and medwatch with patient identifier (b)(6) for information on the ft3 iii results.It was asked but not known if erroneous results from the customer site were reported outside of the laboratory.There was no allegation of an adverse event.The customer's cobas e801 serial number was (b)(4).The serial number for the cobas e801 used at the investigation site was (b)(4).The ft4 iii reagent lot used on this cobas e801 was 380330 with an expiration date of 31-dec-2019.The ft3 iii reagent lot used on this cobas e801 was 372451 with an expiration date of 31-oct-2019.The serial number for the cobas e602 used at the investigation site was (b)(4).The ft3 iii reagent lot used on this cobas e602 was 372451 with an expiration date of 30-nov-2019.The serial number for the cobas e411 used at the investigation site was (b)(4).The tsh reagent lot used on this cobas e411 was 373386 with an expiration date of 30-jun-2019.The ft4 iii reagent lot used on this cobas e411 was 378826 with an expiration date of 31-aug-2019.The ft3 iii reagent lot used on this cobas e411 was 341685 with an expiration date of 30-jun-2019.The investigation is ongoing.
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Based on the data provided, a general reagent issue can be excluded.The investigation concluded that all the thyroid parameter results were in concordance to the normal reference ranges of the respective methods.The mathematically differences in the thyroid values between the various platforms are most likely due to the fact that assays from different vendors can generate different values.This relates to the overall setups of the assays, the antibodies used, and differences in reference materials and the standardization methodology used.The investigation did not identify a product problem.The cause of the event could not be determined.
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