The initial reporter received questionable elecsys ft3 iii results for 1 patient sample on a cobas e 801 module, serial number (b)(4).This medwatch covers the alleged results for the ft3 assay.Please refer to medwatch mdr-47440 for the alleged tsh assay results and mdr-47441 for the alleged ft4 assay results.(b)(4).The results were reported to the patient's physician, who requested the sample test be repeated.
|
The patient's sample was returned for investigation.Based on the results generated, the investigation determined an interfering factor was present in the sample.The different results are consistent with a physical reaction to the ft3 assay and the effect of the interfering factor.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 investigation did not identify a product problem.
|