ELECSYS FT3 III

Additional Manufacturer Narrative

THE CUSTOMER¿S E801 MODULE SERIAL NUMBER WAS NOT PROVIDED. THE E801 MODULE SERIAL NUMBER USED AT THE INVESTIGATION SITE WAS (B)(6). THE E411 ANALYZER SERIAL NUMBER WAS (B)(6). THE COMPETITOR METHOD WAS ABBOTT ARCHITECT. 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 FT3 III REAGENT LOT NUMBER USED WITH THE E411 ANALYZER WAS 686656 WITH AN EXPIRATION DATE OF 30-APR-2024. THE PATIENT SAMPLE WAS REQUESTED FOR FURTHER INVESTIGATION.

Description of Event or Problem

THE INITIAL REPORTER QUESTIONED THE RESULTS FOR 1 PATIENT SAMPLE TESTED FOR TSH ELECSYS E2G 300 V2 (TSH), ELECSYS FT3 III (FT3 III) AND ELECSYS FT4 IV (FT4 IV) ON A COBAS 8000 E 801 MODULE. THE DATE OF THE EVENT IS AN APPROXIMATION. THE DATE OF THE INITIAL RESULTS AT THE CUSTOMER SITE WAS NOT KNOWN. THE SAMPLE WAS SUBMITTED FOR INVESTIGATION AND DISCREPANT RESULTS WERE IDENTIFIED FOR FT3 III BETWEEN THE CUSTOMER¿S E801 MODULE, AN E801 MODULE AT THE INVESTIGATION SITE, A COBAS E411 ANALYZER AT THE INVESTIGATION SITE, AND A COMPETITOR METHOD.

Additional Manufacturer Narrative

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

Additional Manufacturer Narrative

THE SAMPLE WAS SUBMITTED FOR FURTHER INVESTIGATION. THE INVESTIGATION DETERMINED THE PATIENT'S SAMPLE CONTAINED AN INTERFERING FACTOR AGAINST THE FT3 ANTIBODY/IDIOTYPE COMPONENT OF THE REAGENT. THIS INTERFERENCE CAUSED THE HIGH FT3 III RESULTS. 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.