ELECSYS FT3 III

Additional Manufacturer Narrative

FURTHER INVESTIGATIONS OF THE PATIENT SAMPLE DETERMINED THAT IT CONTAINS AN INTERFERING FACTOR AGAINST THE RUTHENIUM LABEL OF THE FT3 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 INVESTIGATION DID NOT IDENTIFY A PRODUCT ISSUE.

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS FT3 III ON TWO COBAS 8000 E 801 MODULE ANALYZERS AND A COBAS E 411 ANALYZER. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. REFER TO THE ATTACHMENT FOR ALL PATIENT DATA. DATA HIGHLIGHTED IN YELLOW WAS QUESTIONED. THE CUSTOMER TESTED THE SAMPLE ON THEIR E 801 ANALYZER ON (B)(6) 2023. THE CUSTOMER REPEATED THE SAMPLE USING THE WAKO ACCURASEED AND ABBOTT ALINITY METHODS. THE CUSTOMER ALSO TREATED THE SAMPLE WITH A 25 % POLYETHYLENE GLYCOL SOLUTION AND REPEATED TESTING ON THEIR E 801 ANALYZER. THE SAMPLE WAS PROVIDED FOR INVESTIGATION, WHERE IT WAS TESTED ON A SECOND E 801 ANALYZER AND AN E411 ANALYZER ON (B)(6) 2023.

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE E 801 ANALYZER USED AT THE CUSTOMER SITE WAS REQUESTED, BUT NOT PROVIDED. THE FT3 REAGENT LOT NUMBER AND EXPIRATION DATE USED ON THIS ANALYZER ARE NOT KNOWN. THE SERIAL NUMBER OF THE E 801 ANALYZER USED FOR INVESTIGATION C231-05. FT3 REAGENT LOT NUMBER 669112, WITH AN EXPIRATION DATE OF 01-FEB-2024 WAS USED ON THIS ANALYZER. THE SERIAL NUMBER OF THE E411 ANALYZER USED FOR INVESTIGATION IS 65G1-25. FT3 REAGENT LOT NUMBER 686656, WITH AN EXPIRATION DATE OF 01-APR-2024 WAS USED ON THIS ANALYZER.