The customer submitted 1 patient sample for investigation that had been tested for elecsys ft4 ii assay (ft4 ii), elecsys tsh assay (tsh) and elecsys ft3 iii (ft3 iii) on a cobas 8000 e 602 module.During the investigation, erroneous ft4 ii and ft3 iii results were identified between the customer's e602 module, an e602 module used at the investigation site and an cobas e 411 immunoassay analyzer used at the investigation site.The results from the customer site were not reported outside of the laboratory.This medwatch will cover ft4 ii.Refer to medwatch with (b)(6) information on the ft3 iii erroneous results.There was no allegation that an adverse event occurred.The e602 module serial number used at the investigation site was (b)(4).The e411 analyzer serial number was (b)(4).The ft4 ii reagent lot number used at the investigation site was 265631 with an expiration date of sep-2018.The serial number for the customer's e602 module is not known.
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The patient sample was submitted for investigation.The customer's ft4 ii and ft3 iii results were reproduced.Upon further investigation of the patient sample, an interferent against a component of the reagent was confirmed.This most likely caused the discrepant ft4 ii and ft3 iii results.This interference is covered in product labeling.Product labeling states "in rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur.These effects are minimized by suitable test design.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings." the incidence rate of the identified interfering factor is monitored on a quarterly basis.
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