ELECSYS FT3 III

Additional Manufacturer Narrative

THE INVESTIGATION DETERMINED THAT A GENERAL REAGENT ISSUE CAN BE EXCLUDED. IN CASE A SAMPLE IS ANALYZED WITH DIFFERENT ANALYZERS, THE GENERATED VALUES ARE TO BE INTERPRETED IN RELATION TO THE NORMAL REFERENCE RANGES OF THE ASSAYS OF THE DIFFERENT ANALYZERS. 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.

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR 3 PATIENTS SAMPLES TESTED WITH ELECSYS FT4 III (FT4 G3) ASSAY, FT3 III V2 (FT3 G3 V2) ASSAY AND TSH V2 ASSAY ON A COBAS 8000 E801 MODULE. THE SAMPLES ALSO HAD DISCREPANTS RESULTS WHEN TESTED ON ANOTHER COBAS 8000 E801 MODULE AND ON A COBAS E411 IMMUNOASSAY ANALYZER. THIS MEDWATCH WILL APPLY TO THE FT3 G3 V2 ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FT4 G3 ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE TSH V2 ASSAY. THE SAMPLES WERE INITIALLY TESTED ON THE CUSTOMER'S E801 ANALYZER. THE SAMPLES WERE PROVIDED FOR INVESTIGATION WHERE THEY TESTED ON A 2ND E801 ANALYZER ON (B)(6) 2023 AND ON E411 ANALYZER ON (B)(6) 2023. THE SAMPLES WERE ALSO REPEATED ON AN ABBOTT ARCHITECT ANALYZER ON (B)(6) 2023. THE SERIAL NUMBER OF THE CUSTOMER'S E801 ANALYZER WAS REQUESTED BUT NOT PROVIDED. THE SERIAL NUMBER OF E801 ANALYZER USED FOR INVESTIGATION IS (B)(4). THE SERIAL NUMBER OF E411 ANALYZER USED FOR INVESTIGATION IS (B)(4). THE FT4 G3 REAGENT LOT NUMBER AND EXPIRATION DATE USED AT THE CUSTOMER'S SITE WERE NOT PROVIDED. THE FT4 G3 REAGENT LOT NUMBER USED ON COBAS E801 WAS 630888 AND THE FT4 G3 REAGENT LOT NUMBER USED ON COBAS E411 WAS 623234. THE EXPIRATION DATES WERE NOT PROVIDED. THE TSH V2 REAGENT LOT NUMBER AND EXPIRATION DATE USED AT THE CUSTOMER'S SITE WERE NOT PROVIDED. THE TSH V2 REAGENT LOT NUMBER USED ON COBAS E801 WAS 653314 AND THE TSH V2 REAGENT LOT NUMBER USED ON COBAS E411 WAS 652947. THE EXPIRATION DATES WERE NOT PROVIDED.