BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION® XPAND PLUS WITH HM

    MDR report key: 2931767 · Received January 28, 2013

    Report

    Report Number
    1226181-2013-00040
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 4, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC- BROOKFIELD
    Product Code
    MMI
    PMA / PMN Number
    K010061
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. AFTER ANALYZING THE INSTRUMENT AND INSTRUMENT DATA THE FSE DETERMINED THAT THE CAUSE OF THE DISCREPANT TROPONIN RESULTS WAS UNKNOWN. THE FSE ALIGNED THE HETEROGENEOUS MODULE (HM) PROBES, DE-CONTAMINATED THE SYSTEM, PERFORMED A FUNCTIONAL CHECK ON THE SYSTEM AND RAN QUALITY CONTROLS. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT TROPONIN RESULTS WERE GENERATED BY THE DIMENSION XPAND PLUS WITH HM SYSTEM. THE RESULTS WERE REPORTED OUT OF THE LABORATORY. THE CUSTOMER RETESTED THE SAMPLES ON THIS SYSTEM AND A BACK-UP SYSTEM AND OBTAINED RESULTS WITHIN EXPECTATIONS. CORRECTED RESULTS WERE ISSUED. THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES OR KNOWN PATIENT INTERVENTION DUE TO THE DISCORDANT TROPONIN RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36448 DIMENSION® XPAND PLUS WITH HM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI SIEMENS HEALTHCARE DIAGNOSTICS INC- BROOKFIELD DIMENSION® XPAND PLUS WITH HM

    Patients

    Seq Age Sex Outcome Treatment
    1