ELECSYS FT3

Additional Manufacturer Narrative

THE PATIENT SAMPLE WAS RECEIVED FOR INVESTIGATION. THE INVESTIGATION WAS NOT ABLE TO CONFIRM THE CUSTOMER'S RESULTS. THIS IS CONSISTENT WITH THE DECREASING IMPACT OF IDIOTYPE INTERFERENCE OVER TIME AND FREEZE-THAW CYCLES. THE INVESTIGATION TESTED THE PATIENT SAMPLE FOR THE PRESENCE OF INTERFERENCE USING A MODIFIED VERSION OF THE FT3 III ASSAY CONTAINING A POLYCLONAL ANTIBODY. THE INVESTIGATION CONFIRMED THE PRESENCE IN THE PATIENT SAMPLE OF AN INTERFERING FACTOR AGAINST THE FT3 ANTIBODY/IDIOTYPE OF THE ASSAY. 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.

Additional Manufacturer Narrative

THE REAGENT LOT NUMBER OF THE FT3 III ASSAY USED AT THE CUSTOMER'S LABORATORY WAS REQUESTED BUT NOT PROVIDED. THE REAGENT LOT NUMBER OF THE FT3 III ASSAY USED AT THE INVESTIGATION LABORATORY'S E 801 IS 669112 WITH AN EXPIRATION DATE OF 29-FEB-2024. THE REAGENT LOT NUMBER OF THE FT3 III ASSAY USED AT THE INVESTIGATION LABORATORY'S E 411 IS 686656 WITH AN EXPIRATION DATE OF 30-APR-2024. THE SERIAL NUMBER OF THE CUSTOMER'S COBAS 8000 CORE UNIT IS 17G9-06. THE SERIAL NUMBER OF THE INVESTIGATION LABORATORY'S COBAS E 801 MODULE IS (B)(6). THE SERIAL NUMBER OF THE INVESTIGATION LABORATORY'S COBAS E 411 ANALYZER IS (B)(6). THE PATIENT SAMPLE WAS REQUESTED FOR INVESTIGATION. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS FT3 III V2 RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE CUSTOMER'S COBAS 8000 CORE UNIT AND THE INVESTIGATION LABORATORY'S COBAS E 801 MODULE AND COBAS E 411 ANALYZER. THE REPORTER STATED THEY NOTED THE DISCREPANT RESULTS BETWEEN THEIR COBAS 8000 CORE UNIT AND THEIR WAKO ACCURASEED AND ABBOTT ALINITY ANALYZERS; THEY SUSPECTED AN INTERFERENCE WITH T3 MONOCLONAL ANTIBODY. THE PATIENT SAMPLE WAS THEN SENT TO THE INVESTIGATION LABORATORY FOR FURTHER ANALYSIS. PLEASE REFER TO THE ATTACHMENT PT-0067373 IN THE MEDWATCH FOR THE TABLE CONTAINING THE HIGHLIGHTED QUESTIONABLE RESULTS.