BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION XPAND PLUS WITH HM

    MDR report key: 3140583 · Received May 31, 2013

    Report

    Report Number
    1226181-2013-00250
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 8, 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 ADVISED THE CUSTOMER TO CLEAN, CALIBRATE, AND ALIGN THE HM MIXERS, CHECK THE HM PUMP CASSETTES, AND ALIGN THE HM WASH PROBES, WHICH THE CUSTOMER DID. THE EXPECTED RESULT HAD BEEN OBTAINED ON THE SAMPLE WITH THE INSTRUMENT PRIOR TO THE TSC BEING CONTACTED. THE CUSTOMER HAD ALSO RERUN OTHER PATIENT SAMPLES AND ALL HAD REPEATED THE SAME AS THE INITIAL RUN. 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 WITH HM INSTRUMENT. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S). THE PATIENT WAS TREATED AND TRANSFERRED TO ANOTHER FACILITY. THE PATIENT WAS REDRAWN AND TESTED AT THE OTHER FACILITY AND THE REDRAW SAMPLE(S) RESULTED LOWER. THE INITIAL SAMPLE WAS THEN RERUN ON THE SAME INSTRUMENT AND RESULTED LOWER. THE REDRAW AND RERUN RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE MEDICATIONS ASA, RAMIPRIL, LIPITOR, AND METAPROLOL WERE ADMINISTERED TO THE PATIENT. 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
    240989 DIMENSION XPAND PLUS WITH HM CLINICAL CHEMISTRY ANALYZER MMI SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION XPAND PLUS W/HM

    Patients

    Seq Age Sex Outcome Treatment
    1