BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP TROPONIN ULTRA ASSAY

    MDR report key: 3150345 · Received June 6, 2013

    Report

    Report Number
    1219913-2013-00130
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 5, 2013
    Report Date
    May 16, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MMI
    PMA / PMN Number
    K053020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT ADVIA CENTAUR XP TROPONIN ULTRA RESULT IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATION. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. THE INSTRUCTION FOR USE UNDER THE SUMMARY AND EXPLANATION OF THE TEST SECTION STATES THE FOLLOWING: "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."

    Description of Event or Problem · 1

    A FALSE POSITIVE ADVIA CENTAUR XP TROPONIN ULTRA RESULT WAS OBTAINED ON A PATIENT SAMPLE. REPEAT TESTING WAS PERFORMED AND THE RESULT WAS NEGATIVE. THE PATIENT SAMPLE WAS TESTED ON A SECOND INSTRUMENT AND THE RESULT WAS HIGHER THAN THE REPEAT. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TROPONIN ULTRA RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249685 ADVIA CENTAUR XP TROPONIN ULTRA ASSAY TROPONIN IMMUNOASSAY MMI SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 071

    Patients

    Seq Age Sex Outcome Treatment
    1