ELECSYS FT3 III

Additional Manufacturer Narrative

THE PATIENT SAMPLE WAS RECEIVED FOR INVESTIGATION. THE INVESTIGATION DETERMINED THAT THE PATIENT SAMPLE CONTAINS AN INTERFERING FACTOR AGAINST THE IDIOTYPE OF THE MONOCLONAL ANTIBODY OF THE FT3 ASSAY. THIS INTERFERENCE IS COVERED IN PRODUCT LABELING. PER PRODUCT LABELING, "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." THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

Additional Manufacturer Narrative

THE ANALYZER SERIAL NUMBER IS (B)(6). THE PATIENT SAMPLE WAS REQUESTED FOR INVESTIGATION. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FT3 III RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 MODULE. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA.