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The customer questioned results from 5 patient samples tested for elecsys tsh (tsh), elecsys ft3 iii (ft3 iii) and elecsys ft4 (ft4) on a cobas e801 module.The customer provided the 5 patient samples for investigation.Of the data provided, erroneous tsh results were identified for 4 patient samples and erroneous ft3 iii and ft4 results were identified for 1 patient sample when tested on the customer's e 801 analyzer, a siemens centaur analyzer, 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 the initial results from the customer site were reported outside of the laboratory.This medwatch will cover ft4.Refer to medwatch with a1 patient identifier (b)(6) for information on the ft3 iii erroneous results and medwatch with a1 patient identifier (b)(6) for information on the tsh erroneous results.Refer the attached data 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 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 elecsys ft4 ii assay (ft4 ii) reagent lot number used with the e602 module was 265631 with an expiration date of (b)(6) 2018.The ft4 ii reagent lot number used with the e411 analyzer was 270341 with an expiration date of (b)(6) 2018.The ft4 ii reagent lot number used with the e801 module at the investigation site was (b)(6) with an expiration date of (b)(6) 2018.Patient sample id (b)(6) was submitted for investigation.The ft3 iii results were higher than the reference range.The ft4 ii and tsh results were within the reference range.Based on the investigation performed, an interfering factor to the assay was not identified.
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