BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION XPAND PLUS WITH HM

    MDR report key: 2944737 · Received February 5, 2013

    Report

    Report Number
    1226181-2013-00059
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 8, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JGS
    PMA / PMN Number
    K010061
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATION OF THE INSTRUMENT AND INSTRUMENT DATA, THE FSE DETERMINED THAT THE INTEGRATED MULTISENSOR TECHNOLOGY SYSTEM SHOULD BE BLEACHED, WHICH WAS THEN DONE. THE FSE ALSO REPLACED A SENSOR AND RAN THE DILCHK. THE FSE THEN CORRECTED THE BIAS ON THE DILCHK SO THAT IT WAS ACCEPTABLE. THE CUSTOMER WAS REMINDED HOW CORRECT THE DILCHK FACTOR. THE CAUSE OF THE DISCORDANT SODIUM, CHLORIDE, AND POTASSIUM RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT SODIUM, CHLORIDE, AND POTASSIUM RESULTS WERE OBTAINED ON PATIENT SAMPLES ON THE DIMENSION XPAND PLUS WITH HM INSTRUMENT. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE RERUN MULTIPLE TIMES AND THE RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT SODIUM, CHLORIDE, AND POTASSIUM RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48118 DIMENSION XPAND PLUS WITH HM IMMUNOASSAY ANALYZER JGS SIEMENS HEALTHCARE DIAGNOSTICS DIMENSION XPAND WITH HM

    Patients

    Seq Age Sex Outcome Treatment
    1