ELECSYS FT3 III

Additional Manufacturer Narrative

FURTHER INVESTIGATIONS OF THE PATIENT SAMPLE DETERMINED THAT IT CONTAINED AN INTERFERING FACTOR AGAINST THE FT3 ASSAY ANTIBODY/IDIOTYPE. 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."

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS FT3 III ON TWO COBAS E 801 MODULE ANALYZERS AND A COBAS E 411 ANALYZER. THE SPECIFIC DATE OF THE EVENT IS NOT KNOWN. REFER TO THE ATTACHMENT FOR ALL PATIENT DATA. THE SAMPLE WAS INITIALLY TESTED ON THE CUSTOMER'S E 801 ANALYZER ON AN UNKNOWN DATE. THE SAMPLE WAS PROVIDED FOR INVESTIGATION, WHERE IT WAS TESTED ON A SECOND E 801 ANALYZER AND AN E411 ANALYZER ON (B)(6) 2023. THE SAMPLE WAS ALSO REPEATED ON A COMPETITOR SYSTEM.

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE CUSTOMER'S E 801 ANALYZER WAS REQUESTED, BUT NOT PROVIDED. THE SERIAL NUMBER OF THE E 801 ANALYZER USED FOR INVESTIGATION IS (B)(6). FT3 REAGENT LOT NUMBER 669112 WITH EXPIRATION DATE 29-FEB-2024 WAS USED ON THIS ANALYZER. THE SERIAL NUMBER OF THE E411 ANALYZER USED FOR INVESTIGATION IS (B)(6). FT3 REAGENT LOT NUMBER 686656 WITH EXPIRATION DATE 30-APR-2024 WAS USED ON THIS ANALYZER. THE COMPETITOR METHOD IS ABBOTT ARCHITECT. THE INVESTIGATION IS ONGOING.

Additional Manufacturer Narrative

**UDI RELATED DATA QUALITY UPDATES ONLY** D3 IS THE INITIAL DISTRIBUTOR IN THE US.