ELECSYS FT3 III

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FT3 III RESULTS FOR 1 PATIENT SAMPLE ON TWO COBAS E 801 MODULES AND A COBAS E 411 IMMUNOASSAY ANALYZER COMPARED TO A WAKO ACCURASEED ANALYZER AND AN ABBOTT ALINITY ANALYZER. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA.

Additional Manufacturer Narrative

THE CUSTOMER'S E801 ANALYZER SERIAL NUMBER AND FT3 REAGENT LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED. (B)(6). THE FT3 REAGENT LOT NUMBER USED ON THE E411 ANALYZER IS 686656 AND THE EXPIRATION DATE IS 30-APR-2024. THE CUSTOMER SUSPECTS AN INTERFERING FACTOR IN THE PATIENT SAMPLE. THE PATIENT SAMPLE WAS REQUESTED FOR INVESTIGATION. THE INVESTIGATION IS ONGOING.

Additional Manufacturer Narrative

THE PATIENT SAMPLE WAS RECEIVED FOR INVESTIGATION. THE INVESTIGATION FOUND THAT THE PATIENT SAMPLE CONTAINS AN INTERFERING FACTOR AGAINST THE FT3 ANTIBODY/IDIOTYPE COMPONENT OF THE REAGENT. 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.