ELECSYS FT3 III

Additional Manufacturer Narrative

THE INVESTIGATION DETERMINED THAT A GENERAL REAGENT ISSUE CAN BE EXCLUDED. ASSAYS FROM DIFFERENT MANUFACTURERS CAN GENERATE DIFFERENT RESULTS. THIS RELATES TO THE OVERALL SETUPS OF THE ASSAYS, THE ANTIBODIES USED, DIFFERENCES IN REFERENCE MATERIALS, AND THE STANDARDIZATION METHODOLOGY USED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR 1 PATIENT¿S SAMPLE TESTED WITH ELECSYS TSH V2 (TSH V2) ASSAY, ELECSYS FT4 G4 (FT4 IV) ASSAY AND ELECSYS FT3 G3 V2 (FT3 III V2) ASSAY ON A COBAS E801 MODULE AND ON A COBAS E411 MODULE. FROM THE SAMPLE, THERE WERE 1 DISCREPANT RESULT FOR TSH V2 TEST, 1 DISCREPANT RESULT FOR FT4 IV TEST AND 1 DISCREPANT RESULT FOR FT3 III V2 TEST. THIS MEDWATCH WILL APPLY TO THE FT3 III V2 ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE TSH V2 ASSAY AND TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FT4 IV ASSAY. REFER TO THE ATTACHMENT FOR THE PATIENT¿S DATA. ON 27-APR-2023 THE SAMPLE WAS INITIALLY TESTED ON THE CUSTOMER'S E801 ANALYZER AND REPEATED ON THE SAME ANALYZER. THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY. ON 28-APR-2023 THE SAMPLE WAS THEN PROVIDED FOR INVESTIGATION WHERE IT WAS TESTED ON A 2ND E801 ANALYZER AND ON AN E411 ANALYZER. ON 9-MAY-2023 THE SAMPLE WAS ALSO REPEATED ON AN ABBOTT ARCHITECT ANALYZER. THE SERIAL NUMBER OF THE CUSTOMER'S E801 ANALYZER WAS NOT PROVIDED. THE FT3 III V2 REAGENT LOT NUMBER AND EXPIRATION DATE WERE REQUESTED BUT NOT PROVIDED. THE TSH V2 REAGENT LOT NUMBER AND EXPIRATION DATE WERE REQUESTED BUT NOT PROVIDED. THE FT4 IV REAGENT LOT NUMBER AND EXPIRATION DATE WERE REQUESTED BUT NOT PROVIDED. THE FT4 III REAGENT LOT NUMBER AND EXPIRATION DATE WERE REQUESTED BUT NOT PROVIDED. THE SERIAL NUMBER OF THE E801 ANALYZER USED FOR INVESTIGATION WAS (B)(4). THE FT3 III V2 REAGENT LOT NUMBER WAS 611920. THE EXPIRATION DATE WAS NOT PROVIDED. THE TSH V2 REAGENT LOT NUMBER WAS 674689. THE EXPIRATION DATE WAS NOT PROVIDED. THE FT4 IV REAGENT LOT NUMBER WAS 670634. THE EXPIRATION DATE WAS NOT PROVIDED. THE FT4 III REAGENT LOT NUMBER WAS 630888. THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED. THE SERIAL NUMBER OF THE E411 ANALYZER USED FOR INVESTIGATION WAS (B)(4). THE FT3 III V2 REAGENT LOT NUMBER WAS 611918. THE EXPIRATION DATE WAS NOT PROVIDED. THE TSH V2 REAGENT LOT NUMBER WAS 660341. THE EXPIRATION DATE WAS NOT PROVIDED. THE FT4 IV REAGENT LOT NUMBER WAS 663936. THE EXPIRATION DATE WAS NOT PROVIDED. ALL REAGENTS' LOTS WERE WELL WITHIN THEIR LIFE-CYCLE AT THE TIME OF THE EVENT.