BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP TROPONIN ULTRA ASSAY

    MDR report key: 3062696 · Received April 17, 2013

    Report

    Report Number
    1219913-2013-00076
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    March 20, 2013
    Report Date
    March 21, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MMI
    PMA / PMN Number
    K053020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT SAMPLE WAS SENT TO AN ALTERNATE LABORATORY FOR HETEROPHILIC ANTIBODY TESTING AND THE RESULT WAS POSITIVE. THE CAUSE FOR THE DISCORDANT ADVIA CENTAUR XP TROPONIN ULTRA RESULT MAY BE DUE TO INTERFERENCE. QUALITY CONTROLS WERE WITHIN RANGE. SIEMENS HEALTHCARE DIAGNOSTICS HAS REQUESTED A PATIENT SAMPLE. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATION. THE INSTRUCTION FOR USE UNDER THE SUMMARY AND EXPLANATION OF THE TEST SECTION STATES "ALWAYS ANALYZE TNI RESULTS IN THE CONTEXT OF TIME ELAPSED SINCE PATIENT PRESENTATION TO THE HOSPITAL. SERIAL SAMPLING IS RECOMMENDED TO DETECT THE TEMPORAL RISE AND FALL OF TROPONIN LEVELS CHARACTERISTIC OF MYOCARDIAL INFARCTION (MI). IN ACCORD WITH PUBLISHED RECOMMENDATIONS, SERIAL TESTING OF TNI AT INTERVALS OF 2 TO 4 HOURS FOR UP TO 12 TO 24 HOURS IS SUGGESTED TO CORROBORATE A SINGLE TNI RESULT. AN ELEVATED TROPONIN ALONE IS NOT SUFFICIENT TO MAKE THE DIAGNOSIS OF MI. OTHER MARKERS, SUCH AS CK-MB AND MYOGLOBIN, CAN BE USED IN CONJUNCTION WITH TNI RESULTS IN AIDING THE DIAGNOSIS OF MI." THE INSTRUCTION FOR USE UNDER THE LIMITATIONS SECTION STATES: "HETEROPHILIC ANTIBODIES IN HUMAN SERUM CAN REACT WITH REAGENT IMMUNOGLOBULINS, INTERFERING WITH IN VITRO IMMUNOASSAYS."

    Description of Event or Problem · 1

    A FALSE POSITIVE ADVIA CENTAUR XP TROPONIN ULTRA RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE RESULTS WERE CONSIDERED DISCORDANT WHEN COMPARED TO AN ALTERNATE LABORATORY TEST METHOD RESULT AND PATIENT'S CLINICAL PICTURE. SERIAL DILUTIONS WERE PERFORMED ON THE PATIENT SAMPLE AND THE RESULTS REMAINED ELEVATED. HETEROPHILIC TESTING ON THE PATIENT SAMPLE WAS COMPLETED AT A SECOND ALTERNATE LABORATORY AND THE TEST RESULT WAS POSITIVE. THERE WAS NO REPORT OF PATIENT TREATMENT BEING PRESCRIBED OR ALTERED AND THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP TROPONIN ULTRA RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165129 ADVIA CENTAUR XP TROPONIN ULTRA ASSAY TROPONIN IMMUNOASSAY MMI SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 070

    Patients

    Seq Age Sex Outcome Treatment
    1