BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION XPAND PLUS WITH HM

    MDR report key: 2840793 · Received November 20, 2012

    Report

    Report Number
    1226181-2012-00128
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    October 26, 2012
    Report Date
    October 26, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    MMI
    PMA / PMN Number
    K010061
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE ANALYZED THE INSTRUMENT AND DETERMINED THE CAUSE OF THE DISCORDANT HIGH CTNI RESULTS WAS DUE TO THE BIO-FILM CONTAMINATION OF THE CHEMISTRY WASH FLUIDICS SYSTEM. THE FSE DECONTAMINATED THE SYSTEM. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. FURTHER EVALUATION OF THE DEVICE IS NOT REQUIRED.

    Description of Event or Problem · 1

    TWO DISCORDANT HIGH RESULTS FOR TROPONIN I (CTNI) WERE OBTAINED ON A DIMENSION XPAND INSTRUMENT. INITIAL RESULTS WERE HIGH (POSITIVE). THEY WERE REPORTED TO THE PHYSICIANS WHO QUESTIONED THE RESULTS. THE SAME SAMPLES WERE RERUN ON ANOTHER DIMENSION XPAND INSTRUMENT IN THE SAME LABORATORY AND NORMAL (NEGATIVE) RESULTS WERE OBTAINED. CORRECTED REPORTS WERE SENT TO THE PHYSICIANS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CTNI RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIMENSION XPAND PLUS WITH HM IMMUNOASSAY ANALYZER MMI SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION XPAND PLUS WITH HM FD3169

    Patients

    Seq Age Sex Outcome Treatment
    1