ELECSYS FT3 III

Additional Manufacturer Narrative

THE SAMPLE WAS RECEIVED FOR INVESTIGATION. THE INVESTIGATION DETERMINED THE PATIENT SAMPLE CONTAINED AN INTERFERING FACTOR AGAINST THE IDIOTYPE OF THE MONOCLONAL ANTIBODY OF THE FT3 ASSAY. THIS INTERFERENCE CAUSED THE HIGH FT3 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.

Description of Event or Problem

THE INITIAL REPORTER QUESTIONED THYROID RESULTS FOR 1 PATIENT SAMPLE TESTED ON A COBAS E801 MODULE. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS SUBMITTED FOR INVESTIGATION WHERE DISCREPANT RESULTS WERE IDENTIFIED FOR ELECSYS FT3 III (FT3 III) BETWEEN THE CUSTOMERS E801 MODULE, THE ACCURASEED WAKO METHOD, AN E801 MODULE USED AT THE INVESTIGATION SITE, A COBAS E 411 IMMUNOASSAY ANALYZER USED AT THE INVESTIGATION SITE AND THE ABBOTT ARCHITECT METHOD. REFER TO THE ATTACHED DATA FOR THE PATIENT RESULTS. THE CUSTOMER¿S E801 MODULE WAS 17G9-06. THE E801 MODULE SERIAL NUMBER USED AT THE INVESTIGATION SITE WAS 14D9-06. THE E411 ANALYZER SERIAL NUMBER USED AT THE INVESTIGATION SITE WAS 65G1-25. THE FT3 III V2 REAGENT LOT NUMBER USED WITH THE E801 MODULE AT THE INVESTIGATION SITE WAS 611920 WITH AN EXPIRATION DATE OF MAY 31, 2023. THE FT3 III V2 REAGENT LOT NUMBER USED WITH THE E411 ANALYZER AT THE INVESTIGATION WAS 611918 WITH AN EXPIRATION DATE OF MAY 30, 2023.

Additional Manufacturer Narrative

THE CUSTOMER PERFORMED TSH DILUTION TESTING WITH ACCEPTABLE RESULTS. THE CUSTOMER TREATED THE SAMPLE IN QUESTION WITH POLYETHYLENE GLYCOL (PEG) AND COMPARED IT TO ANOTHER SAMPLE. THERE WAS NO DECREASE IN THE RECOVERY RATE FOR TSH, FT4, OR FT3. THE SAMPLE WAS REQUESTED FOR FURTHER INVESTIGATION.