ELECSYS FT3 III

Description of Event or Problem

THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS FT4 III (FT4 III) AND ELECSYS FT3 III (FT3 III) ON A COBAS 8000 E 602 MODULE COMPARED TO OTHER METHODS. THIS MEDWATCH WILL COVER FT3 III. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE FT4 III RESULTS. THE FT4 III RESULT FROM THE E602 MODULE WAS 24.11 PMOL/L. ON (B)(6) 2023 THE RESULT FROM THE BECKMAN METHOD WAS 0.64 PMOL/L. ON (B)(6) 2023 THE RESULT FROM THE AUTIBIO METHOD WAS 14.47 PMOL/L. THE FT3 III RESULT FROM THE E602 MODULE WAS 10.57 PMOL/L. ON (B)(6) 2023 THE RESULT FROM THE BECKMAN METHOD WAS 3.30 PMOL/L. ON (B)(6) 2023 THE RESULT FROM THE AUTIBIO METHOD WAS 5.55 PMOL/L. THE CUSTOMER SUSPECTS AN INTERFERENCE AFFECTING THE ROCHE RESULTS.

Additional Manufacturer Narrative

SECTION E1 FACILITY NAME CONTINUED: (B)(6). THE SAMPLE WAS REQUESTED FOR INVESTIGATION.

Additional Manufacturer Narrative

THE SAMPLE WAS RECEIVED FOR INVESTIGATION. THE CUSTOMER'S HIGH FT4 III AND FT3 III RESULTS WERE REPRODUCED. UPON FURTHER INVESTIGATION OF THE PATIENT SAMPLE, AN INTERFERENT AGAINST THE RUTHENIUM COMPONENT OF THE REAGENT WAS CONFIRMED. THIS CAUSED THE HIGH FT3 III AND FT4 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.