ELECSYS FT3

Additional Manufacturer Narrative

THE SAMPLE WAS SUBMITTED FOR INVESTIGATION. UPON FURTHER INVESTIGATION OF THE PATIENT SAMPLE, NO INTERFERING FACTORS WERE IDENTIFIED. 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.

Additional Manufacturer Narrative

THE CUSTOMER¿S COBAS 8000 CORE UNIT SERIAL NUMBER WAS (B)(6). THE CUSTOMER¿S E801 ANALYZER SERIAL NUMBER WAS NOT PROVIDED. THE E411 ANALYZER SERIAL NUMBER USED AT THE INVESTIGATION SITE WAS (B)(6) . THE E801 ANALYZER SERIAL NUMBER USED AT THE INVESTIGATION SITE WAS (B)(6). THE FT3 III V2 REAGENT LOT NUMBER USED WITH THE E411 ANALYZER WAS 686656 WITH AN EXPIRATION DATE OF 30-APR-2024. THE FT3 III V2 REAGENT LOT NUMBER USED WITH THE E801 ANALYZER AT THE INVESTIGATION SITE WAS 737314 WITH AN EXPIRATION DATE OF 30-NOV-2024. THE SAMPLE WAS REQUESTED FOR FURTHER INVESTIGATION.

Description of Event or Problem

THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS FT3 (FT3) AND ELECSYS FT4 III (FT4 III) ON A COBAS E801 ANALYZER COMPARED TO THE WAKO ACCURASEED METHOD AND THE ABBOTT ALINITY METHOD. THIS MEDWATCH WILL COVER FT3. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER PT (B)(6) FOR INFORMATION ON THE FT4 III RESULTS. THE SAMPLE WAS SUBMITTED FOR INVESTIGATION AND TESTED ON A COBAS E801 MODULE AND AN E411 ANALYZER WHERE DISCREPANT FT3 AND FT4 III RESULTS WERE OBTAINED WHEN COMPARED TO THE WAKO AND ABBOTT METHODS. REFER TO THE ATTACHED DATA FOR THE PATIENT RESULTS.