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The customer questioned thyroid results for 3 patient samples tested for elecsys tsh (tsh), elecsys ft4 ii (ft4 ii), and elecsys ft3 iii (ft3 iii) on a cobas e 801 module.The 3 patient samples were submitted for investigation where discrepant results were identified for tsh and ft4 ii between the customer's e801 module, the centaur method, an e801 module used at the investigation site, a cobas 8000 e 602 module used at the investigation site and a cobas e 411 immunoassay analyzer used at the investigation site.It is not known if any incorrect results were reported outside of the laboratory.This medwatch will cover ft4 ii.Refer to medwatch with patient identifier (b)(6) for information on the tsh results.There was no allegation that an adverse event occurred.The serial number for the customer's e801 module was not provided.The patient samples were also treated and underwent polyethylene glycol (peg) testing.Refer to attached data titled "peg testing" for these results.The e602 module serial number was (b)(4).The e411 analyzer serial number was (b)(4).The e801 module serial number used at the investigation site was (b)(4).The ft4 ii reagent lot number used with the e602 module and the e411 analyzer was 288197 with an expiration date of 31-dec-2018.The ft4 ii reagent lot number used with the e801 module at the investigation site was 265662 with an expiration date of 30-nov-2018.Calibration and qc were acceptable at the investigation site.Based on the information provided, a general reagent issue can be excluded.Assays from different manufacturers can generate different results.
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