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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, ft4 ii and ft3 iii 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 tsh.Refer to medwatch with patient identifier (b)(6) for information on the ft4 ii erroneous results and medwatch with patient identifier (b)(6) for information on the ft3 iii erroneous results.Refer to attached data titled "patient results" for the patient 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 tsh reagent lot number used with the e602 module was 291617 with an expiration date of 31-jul-2018.The tsh reagent lot number used with the e411 analyzer was 274071 with an expiration date of 31-may-2018.The tsh reagent lot number used with the e801 module at the investigation site was 283556 with an expiration date of 28-feb-2019.
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