ELECSYS FT3

Additional Manufacturer Narrative

THE E801 ANALYZER SERIAL NUMBER WAS (B)(6) . THE COMPETITOR METHOD WAS TOSOA AIA-600. THE SAMPLE WAS REQUESTED FOR INVESTIGATION.

Description of Event or Problem

THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS FT3 III (FT3 III), AND ELECSYS FT4 IV (FT4 IV) ON A COBAS E 801 ANALYTICAL UNIT COMPARED TO A COMPETITOR METHOD. THIS MEDWATCH WILL COVER FT3 III. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE FT4 IV RESULTS. ON (B)(6) 2024 THE FT3 III RESULT FROM THE E801 ANALYZER WAS 22.1 PG/ML. ON (B)(6) 2024 THE FT4 IV RESULT FROM THE E801 ANALYZER WAS 6.68 NG/DL. THE PATIENT WAS MOVED TO A DIFFERENT HOSPITAL. ON (B)(6) 2024 THE THYROID RESULTS FROM THE OTHER HOSPITAL WERE "NORMAL." DUE TO THE "NORMAL" RESULTS FROM THE OTHER HOSPITAL, THE CUSTOMER SENT THE PATIENT SAMPLE TO AN EXTERNAL LABORATORY FOR TESTING BY A COMPETITOR METHOD. ON (B)(6) 2024 THE FT3 RESULT FROM THE COMPETITOR METHOD WAS 3.7 PG/ML. ON (B)(6) 2024 THE FT4 RESULT FROM THE COMPETITOR METHOD WAS 1.5 NG/DL.

Additional Manufacturer Narrative

A NEW SAMPLE WAS OBTAINED FROM THE PATIENT ON (B)(6) 2024. THE RESULTS WERE SIMILAR TO THE INITIAL RESULTS FROM (B)(6) 2024. THE SAMPLE WAS SUBMITTED FOR INVESTIGATION AND DISCREPANT RESULTS WERE IDENTIFIED FOR FT3 III AND FT4 IV BETWEEN THE CUSTOMER'S E801 ANALYZER, AN E801 ANALYZER USED AT THE INVESTIGATION SITE, AN E411 ANALYZER USED AT THE INVESTIGATION SITE AND THE ABBOTT ARCHITECT METHOD. SEE THE ATTACHED DATA FOR THE PATIENT RESULTS. THE E801 ANALYZER USED AT THE INVESTIGATION SITE WAS (B)(4). THE E411 ANALYZER USED AT THE INVESTIGATION SITE WAS (B)(4). THE FT3 III V2 REAGENT LOT NUMBER USED WITH THE E411 ANALYZER WAS (B)(4) WITH AN EXPIRATION DATE OF 31-APR-2024. THE FT3 III V2 REAGENT LOT NUMBER USED WITH THE E801 ANALYZER WAS (B)(4) WITH AN EXPIRATION DATE OF 30-NOV-2024. THE FT4 IV REAGENT LOT NUMBER USED AT THE INVESTIGATION SITE WAS (B)(4) WITH AN EXPIRATION DATE OF 31-MAY-2024. THE INVESTIGATION IS ONGOING.

Additional Manufacturer Narrative

THE INVESTIGATION DETECTED AN INTERFERING FACTOR IN THE SAMPLE CAUSING FALSELY ELEVATED VALUES WITH ELECSYS FT3 III AND FT4 IV ASSAYS. A GENERAL PRODUCT PROBLEM CAN BE EXCLUDED. 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. THE CAUSE OF THE EVENT WAS DUE TO A KNOWN INTERFERENT FOUND IN THE PATIENT'S SAMPLE.