BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR CP TROPONIN ULTRA ASSAY

    MDR report key: 3172266 · Received June 17, 2013

    Report

    Report Number
    1219913-2013-00135
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 21, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MMI
    PMA / PMN Number
    K053020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT ADVIA CENTAUR CP TROPONIN ULTRA RESULT IS UNKNOWN. A SIEMENS FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE FOR SYSTEM INSPECTION. THE FSE REPLACED THE BASE PUMP AND THE INSTRUMENT WAS FULLY FUNCTIONAL UPON DEPARTURE. SUBSEQUENTLY, DUE TO POOR PRECISION, THE FSE RETURNED TWO DAYS LATER TO THE CUSTOMER SITE TO PERFORM ADDITIONAL MAINTENANCE. THE FSE DECONTAMINATED SYSTEM, REPLACED WASH BLOCK DUE TO LEAK, REPLACED BASE PUMP SOLENOID VALVE AND PRIMED SYSTEM. THE FSE RAN A PRECISION TEST FOR ADVIA CENTAUR CP TROPONIN ULTRA AND THE RESULTS WERE GOOD AND WITHIN SPECIFICATION. THE LEAKING WASH BLOCK MAY HAVE CONTRIBUTED TO THE DISCORDANT RESULT, BUT IT IS UNLIKELY TO BE THE CAUSE AS NO OTHER DISCORDANT RESULTS WERE NOTED. NO CONCLUSION CAN BE DRAWN. THE INSTRUCTION FOR USE UNDER THE SUMMARY AND EXPLANATION OF THE TEST SECTION STATES THE FOLLOWING: "ALWAYS ANALYZE CTNI 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 MI. IN ACCORD WITH PUBLISHED RECOMMENDATIONS, SERIAL TESTING OF CTNI AT INTERVALS OF 2 TO 4 HOURS FOR UP TO 12 TO 24 HOURS IS SUGGESTED TO CORROBORATE A SINGLE CTNI 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 CTNI RESULTS IN AIDING THE DIAGNOSIS OF MI.."

    Description of Event or Problem · 1

    DISCORDANT ADVIA CENTAUR CP TROPONIN ULTRA PATIENT SAMPLE TEST RESULTS WERE OBTAINED BY THE CUSTOMER. REPEAT TESTING DID NOT CONFIRM THE INITIAL RESULTS. THE PATIENT SAMPLE WAS REPEATED ON ANOTHER INSTRUMENT AND THE RESULT WAS ALSO 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 CP TROPONIN ULTRA RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273069 ADVIA CENTAUR CP TROPONIN ULTRA ASSAY TROPONIN IMMUNOASSAY MMI SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 072

    Patients

    Seq Age Sex Outcome Treatment
    1