ELECSYS FT3 III

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR 4 PATIENT SAMPLES TESTED WITH THE ELECSYS TSH, THE ELECSYS FT4 III, AND THE ELECSYS FT3 III VER.2 (FT3 V2) ASSAY ON MULTIPLE ROCHE ANALYZERS AND COMPARED TO THE ABBOTT ARCHITECT METHOD. THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THIS MEDWATCH WILL APPLY TO THE FT3 V2 ASSAY. PLEASE REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE TSH ASSAY AND TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FT4 III ASSAY. THE SAMPLES WERE INITIALLY TESTED WITH TSH, FT4 III, AND FT3 V2 ON THE CUSTOMER'S COBAS E 801 MODULE ON AN UNKNOWN DATE. THE SAMPLES WERE PROVIDED FOR INVESTIGATION, WHERE THEY WERE TESTED WITH THE TSH, FT4 III, AND FT3 V2 ASSAYS ON A SECOND E 801 MODULE ON (B)(6) 2023. DURING INVESTIGATIONS, THE SAMPLES WERE ALSO TESTED WITH THE TSH, FT4 III AND FT3 V2 ASSAYS ON A COBAS E 411 ANALYZER ON (B)(6) 2023. THE SAMPLES WERE ALSO REPEATED USING THE ABBOTT ARCHITECT TSH, FT4 AND FT3 METHODS ON (B)(6) 2023. REFER TO THE ATTACHMENT FOR ALL RELEVANT TEST DATA. 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)(4). FT3 V2 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 V2 REAGENT LOT NUMBER 611918, WITH AN EXPIRATION DATE OF 30-MAY -2023 WAS USED ON THIS ANALYZER.

Additional Manufacturer Narrative

THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. ASSAYS FROM DIFFERENT VENDORS CAN GENERATE DIFFERENT VALUES. THIS RELATES TO THE OVERALL SETUPS OF THE ASSAYS, THE ANTIBODIES USED, DIFFERENCES IN REFERENCE MATERIALS/METHODS, AND DIFFERENCES IN THE STANDARDIZATION METHODOLOGY USED.