BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP TROPONIN ULTRA ASSAY

    MDR report key: 3111907 · Received May 14, 2013

    Report

    Report Number
    1219913-2013-00100
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 13, 2013
    Report Date
    April 19, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MMI
    PMA / PMN Number
    K053020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PROTEIN ELECTROPHORESES TESTING WAS PERFORMED ON THE PATIENT SAMPLE AND A IGM PROTEIN MONOCLONAL WAS DETECTED. 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."

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR ON MAY 14, 2013. 11/18/2013 ADDITIONAL INFORMATION: THE INITIAL MDR HAD STATED THAT "SIEMENS HEALTHCARE DIAGNOSTICS HAS REQUESTED A PATIENT SAMPLE". THERE IS NO PATIENT SAMPLE AVAILABLE FOR FURTHER TESTING AND INVESTIGATION. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATION. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    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 TEST METHOD RESULT AND PATIENT'S CLINICAL PICTURE. THE DISCORDANT SAMPLE WAS DILUTED AND THE RESULTS REMAINED ELEVATED. 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
    212289 ADVIA CENTAUR XP TROPONIN ULTRA ASSAY TROPONIN IMMUNOASSAY MMI SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 071

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR