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 (ft3) on a cobas 6000 e 601 module.During the investigation, erroneous ft4 ii and ft3 results were identified between the customer's e601 module and a 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) for information on the ft3 erroneous results.Refer to the attached data for the patient results.There was no allegation that an adverse event occurred.The e411 analyzer serial (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 e601 module is not known.
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The patient sample was submitted for investigation.The customer's ft4 ii and ft3 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 elevated ft4 ii and ft3 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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