ELECSYS FT3 III

Additional Manufacturer Narrative

THE PATIENT SAMPLE WAS RECEIVED FOR INVESTIGATION. THE INVESTIGATION WAS ABLE TO REPRODUCE THE CUSTOMER'S RESULTS. THE PATIENT SAMPLE WAS TESTED FOR THE PRESENCE OF INTERFERENCE. THE INVESTIGATION CONFIRMED THE PRESENCE OF AN INTERFERING FACTOR AGAINST THE FT3 ANTIBODY/IDIOTYPE IN THE PATIENT SAMPLE. THE INVESTIGATION DETERMINED THE EVENT WAS CAUSED BY THE PRESENCE OF THE INTERFERING FACTOR IN THE PATIENT SAMPLE. PRODUCT LABELING STATES "IN RARE CASES, INTERFERENCE DUE TO EXTREMELY HIGH TITERS OF ANTIBODIES TO ANALYTE-SPECIFIC ANTIBODIES, STREPTAVIDIN OR RUTHENIUM CAN OCCUR. THESE EFFECTS ARE MINIMIZED BY SUITABLE TEST DESIGN. FOR DIAGNOSTIC PURPOSES, THE RESULTS SHOULD ALWAYS BE ASSESSED IN CONJUNCTION WITH THE PATIENT¿S MEDICAL HISTORY, CLINICAL EXAMINATION AND OTHER FINDINGS." THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

Additional Manufacturer Narrative

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

Additional Manufacturer Narrative

THE LOT NUMBER OF THE REAGENT USED AT THE INVESTIGATION SITE'S E 801 IS 669112 WITH AN EXPIRATION DATE OF 29-FEB-2024. THE LOT NUMBER OF THE REAGENT USED AT THE INVESTIGATION SITE'S E 411 IS 686656 WITH AN EXPIRATION DATE OF 30-APR-2024. THE SERIAL NUMBER OF THE CUSTOMER'S COBAS 8000 CORE UNIT IS (B)(6). THE SERIAL NUMBER OF THE INVESTIGATION SITE'S COBAS E 801 MODULE IS (B)(6). THE SERIAL NUMBER OF THE INVESTIGATION SITE'S COBAS E 411 MODULE IS (B)(6). THE PATIENT SAMPLE WAS REQUESTED FOR INVESTIGATION. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS FT3 III VER.2 RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE CUSTOMER'S COBAS 8000 CORE UNIT, THE INVESTIGATION SITE'S COBAS E 801, AND THE INVESTIGATION SITE'S COBAS E 411 MODULE. THE PATIENT SAMPLE WAS RERUN ON AN ABBOTT ALINITY ANALYZER AND A WAKO ACCURASEED ANALYZER. THE REPORTER NOTED DISCREPANT RESULTS AND SUSPECTED SOME NONSPECIFIC INTERFERENCE IN THE ROCHE ASSAYS. THE PATIENT SAMPLE WAS THEN SENT TO AN INVESTIGATION LABORATORY FOR RERUNS. PLEASE REFER TO THE ATTACHMENT (B)(6) FOR THE TABLE CONTAINING THE HIGHLIGHTED QUESTIONABLE RESULTS.