BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION XPAND PLUS

    MDR report key: 3121563 · Received May 21, 2013

    Report

    Report Number
    1226181-2013-00235
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 25, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    MMI
    PMA / PMN Number
    K112999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS TECHNICAL SOLUTIONS CENTER (TSC). AFTER EVALUATION OF THE INSTRUMENT DATA, THE TSC SPECIALIST DID NOT FIND AN INSTRUMENT MALFUNCTION. THE TSC SPECIALIST PERFORMED TROUBLESHOOTING WITH THE CUSTOMER, AND THE ISSUE COULD NOT BE REPRODUCED. THE CAUSE OF THE DISCORDANT, FALSELY ELEVATED TROPONIN RESULT ON ONE PATIENT SAMPLE IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT, FALSELY ELEVATED TROPONIN RESULT WAS OBTAINED ON ONE PATIENT SAMPLE ON A DIMENSION XPAND PLUS INSTRUMENT. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO SENT THE PATIENT FOR A CORONARY ANGIOGRAPHY. AFTER THE CORONARY ANGIOGRAPHY TEST, THE PATIENT WAS REDRAWN, AND THE NEW SAMPLE WAS TESTED ON THE SAME INSTRUMENT AND RESULTED LOWER. THE INITIAL SAMPLE WAS THEN RERUN ON THE SAME INSTRUMENT, AND ALSO RESULTED LOWER. THE RERUN RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED TROPONIN RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224803 DIMENSION XPAND PLUS CLINICAL CHEMISTRY ANALYZER MMI SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION XPAND PLUS

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR