ELECSYS FT3 III

Additional Manufacturer Narrative

THE COMPONENT, EVALUATION METHOD, EVALUATION RESULT, AND EVALUATION CONCLUSION CODES HAVE BEEN UPDATED.

Additional Manufacturer Narrative

FURTHER INVESTIGATIONS OF THE PATIENT SAMPLE WERE ABLE TO REPRODUCE THE CUSTOMER'S RESULTS. THE SAMPLE WAS FOUND TO HAVE AN INTERFERING FACTOR AGAINST THE STREPTAVIDIN COMPONENT OF THE FT3 III ASSAY. 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 FT3 CONCENTRATION MEASURED WITH THE FT3 III V 2 ASSAY WAS ABOUT 20% LESS THAN THE CONCENTRATION MEASURED WITH THE FT3 III ASSAY.

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS FT3 III VER. 2 (FT3 III V 2) ON TWO COBAS E 801 MODULES AND A COBAS E 411 IMMUNOASSAY ANALYZER. THE SAMPLE ALSO HAD DISCREPANT RESULTS FOR ELECSYS FT3 III (FT3 III) WHEN TESTED ON THE SECOND E 801 MODULE AND THE E 411 ANALYZER THAT WERE USED FOR INVESTIGATION. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THIS MEDWATCH WILL APPLY TO THE FT3 III V 2 ASSAY. PLEASE REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER . PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FT3 III ASSAY. QUESTIONED VALUES ARE HIGHLIGHTED IN YELLOW. THE SAMPLE WAS INITIALLY TESTED WITH THE FT3 II V 2 ASSAY WHEN TESTED ON THE CUSTOMER'S E 801 MODULE ON 28-JAN-2023. THE SAMPLE WAS REPEATED BY THE CUSTOMER USING THE WAKO ACCURASEED FT3 METHOD. THE CUSTOMER ALSO TREATED THE SAMPLE WITH POLYETHYLENE GLYCOL (PEG) AND REPEATED IT ON THEIR E 801 MODULE. THE SAMPLE WAS PROVIDED FOR INVESTIGATION WHERE IT WAS TESTED WITH FT3 III AND FT3 III V 2 ON A SECOND E 801 ANALYZER AND AN E411 ANALYZER ON 16-FEB-2023. THE SAMPLE WAS ALSO REPEATED USING THE ABBOTT ARCHITECT FT3 METHOD ON 21-FEB-2023. THE SERIAL NUMBER OF THE CUSTOMER'S E 801 MODULE IS (B)(4). THE FT3 III V2 REAGENT LOT NUMBER AND EXPIRATION DATE USED ON THIS ANALYZER WERE NOT PROVIDED. THE SERIAL NUMBER OF THE E 801 MODULE USED FOR INVESTIGATION IS (B)(4). FT3 III V 2 REAGENT LOT NUMBER 611920, WITH AN EXPIRATION DATE OF 31-MAY-2023 WAS USED ON THIS ANALYZER. THE SERIAL NUMBER OF THE E411 ANALYZER USED FOR INVESTIGATION IS (B)(4). FT3 III V 2 REAGENT LOT NUMBER 611918, WITH AN EXPIRATION DATE OF 30-MAY-2023 WAS USED ON THIS ANALYZER.