ELECSYS FT3 III

Additional Manufacturer Narrative

THE PATIENT SAMPLE WAS PROVIDED FOR INVESTIGATION. THE INVESTIGATION FOUND THAT THE PATIENT SAMPLE CONTAINS AN INTERFERING FACTOR TO THE RUTHENIUM COMPONENT OF THE REAGENT. PER PRODUCT LABELING, "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." A GENERAL PRODUCT PROBLEM COULD BE EXCLUDED.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FT3 III RESULTS FOR 2 PATIENT SAMPLES ON A COBAS 6000 E601 MODULE COMPARED TO A COBAS E801 MODULE, A BECKMAN ANALYZER, AND A MINDRAY ANALYZER. THIS MEDWATCH WILL COVER FT3 III. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE FT4 III RESULTS AND MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE ANTI-TSHR RESULTS. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY AS THEY DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS. THE CUSTOMER'S E601 ANALYZER SERIAL NUMBER IS (B)(6). THE INVESTIGATIONAL E801 ANALYZER SERIAL NUMBER WAS REQUESTED BUT NOT PROVIDED.

Additional Manufacturer Narrative

THE SAMPLE IS SUSPECTED OF CONTAINING AN INTERFERING SUBSTANCE. THE INVESTIGATION IS ONGOING.