ELECSYS FT3 III

Additional Manufacturer Narrative

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. FROM THE INFORMATION PROVIDED, A GENERAL REAGENT ISSUE CAN BE EXCLUDED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

Additional Manufacturer Narrative

THE CUSTOMER¿S E801 MODULE SERIAL NUMBER WAS (B)(6). THE E801 MODULE SERIAL NUMBER USED AT THE INVESTIGATION SITE WAS (B)(6). THE E411 ANALYZER SERIAL NUMBER USED AT THE INVESTIGATION SITE WAS (B)(6). THE FT3 III REAGENT LOT NUMBER USED WITH THE E411 ANALYZER WAS 686656 WITH AN EXPIRATION DATE OF 30-APR-2024. THE FT3 III REAGENT LOT NUMBER USED WITH THE E801 MODULE AT THE INVESTIGATION SITE WAS 669112 WITH AN EXPIRATION DATE OF 29-FEB-2024. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER QUESTIONED THE RESULTS FOR 4 PATIENT SAMPLES TESTED FOR ELECSYS TSH (TSH), ELECSYS FT4 IV (FT4 IV) AND ELECSYS FT3 III (FT3 III). THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY WHERE ADDITIONAL TESTING WAS REQUESTED. THE SAMPLES WERE SUBMITTED FOR INVESTIGATION WHERE DISCREPANT RESULTS WERE IDENTIFIED FOR TSH, FT4 AND FT3 III BETWEEN THE CUSTOMER¿S E801 MODULE, AN E801 MODULE USED AT THE INVESTIGATION SITE, A COBAS E 411 IMMUNOASSAY ANALYZER USED AT THE INVESTIGATION SITE AND THE ABBOTT ARCHITECT METHOD. THIS MEDWATCH WILL COVER FT3 III. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE TSH RESULTS AND MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE FT4 RESULTS. REFER TO THE ATTACHED FOR THE PATIENT RESULTS.