ELECSYS FT3

Additional Manufacturer Narrative

THE SAMPLE WAS SUBMITTED FOR INVESTIGATION. UPON FURTHER INVESTIGATION OF THE PATIENT SAMPLE, AN INTERFERENCE AGAINST THE FT3 ANTIBODY/IDIOTYPE COMPONENT OF THE REAGENT WAS CONFIRMED. 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.

Description of Event or Problem

THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS FT3 (FT3) ON A COBAS 8000 CORE UNIT COMPARED TO THE WAKO ACCURASEED METHOD. THE SAMPLE WAS SUBMITTED FOR INVESTIGATION WHERE DISCREPANT FT3 RESULTS WERE ALSO OBTAINED BY THE ABBOTT ALINITY METHOD, A COBAS E801 ANALYZER USED AT THE INVESTIGATION SITE, AND AN E411 ANALYZER USED AT THE INVESTIGATION SITE. REFER TO THE ATTACHED DATA FOR THE PATIENT RESULTS.

Additional Manufacturer Narrative

THE COBAS 8000 CORE UNIT SERIAL NUMBER WAS (B)(6) . THE E411 ANALYZER USED AT THE INVESTIGATION SITE WAS (B)(4). THE E801 ANALYZER USED AT THE INVESTIGATION SITE WAS (B)(4). 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 ANALYZER AT THE INVESTIGATION SITE WAS 737314 WITH AN EXPIRATION DATE OF 30-NOV-2024. THE SAMPLE WAS REQUESTED FOR FURTHER INVESTIGATION.