ELECSYS FT3 III

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR 4 PATIENTS' SAMPLES TESTED WITH ELECSYS FT3 G3 V2 (FT3 III V2) ASSAY, AND TSH V2 (TSH V2) ASSAY ON A COBAS 8000 E801 MODULE. THE SAMPLES ALSO HAD DISCREPANT RESULTS WHEN TESTED ON ANOTHER COBAS 8000 E801 MODULE AND ON A COBAS E411 IMMUNOASSAY ANALYZER. 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. REFER TO THE ATTACHMENT FOR ALL PATIENTS' DATA. 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 AND ON E411 ANALYZER. THE SAMPLES WERE ALSO REPEATED ON AN ABBOTT ARCHITECT ANALYZER.

Additional Manufacturer Narrative

TWO SAMPLES WERE RECEIVED FOR INVESTIGATION ON 18-JAN-2024. UPON INVESTIGATION OF THE SAMPLES, NO INTERFERENCE WAS DETECTED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. PRODUCT LABELING FOR TSH AND FT3 III STATE: FOR DIAGNOSTIC PURPOSES, THE RESULTS SHOULD ALWAYS BE ASSESSED IN CONJUNCTION WITH THE PATIENT´S MEDICAL HISTORY, CLINICAL EXAMINATION, AND OTHER FINDINGS.

Additional Manufacturer Narrative

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)(6). THE SERIAL NUMBER OF E411 ANALYZER USED FOR INVESTIGATION IS (B)(6). THE FT3 III V2 REAGENT EXPIRATION DATE USED AT THE CUSTOMER'S SITE WAS NOT PROVIDED. THE FT3 III V2 REAGENT LOT NUMBER USED ON COBAS E801 WAS 669112 WITH AN EXPIRATION DATE OF 29-FEB-2024. THE FT3 III V2 REAGENT LOT NUMBER USED ON COBAS E411 WAS 686656 WITH AN EXPIRATION DATE OF 30-APR-2024. 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 714216 WITH AN EXPIRATION DATE OF 31-AUG-2024. THE TSH V2 REAGENT LOT NUMBER USED ON COBAS E411 WAS 706442 WITH AN EXPIRATION DATE OF 29-FEB-2024. 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 IS ONGOING.

Additional Manufacturer Narrative

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