BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION XPAND PLUS W/ HM

    MDR report key: 3232740 · Received July 18, 2013

    Report

    Report Number
    1226181-2013-00321
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 20, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JGS
    PMA / PMN Number
    K112999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    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. DURING TROUBLESHOOTING THE TSC SPECIALIST DISCOVERED THAT THE CUSTOMER IS CENTRIFUGING THE PLASMA TUBES FOR TEN MINUTES INSTEAD OF THE TUBE VENDOR SPECIFIED FIFTEEN MINUTES. THE CAUSE OF THE DISCORDANT, FALSELY LOW SODIUM RESULTS IS UNKNOWN. THE CENTRIFUGING OF THE PLASMA TUBES AGAINST TUBE VENDOR SPECIFICATIONS IS FAILURE TO FOLLOW INSTRUCTIONS. THIS INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT, FALSELY LOW SODIUM RESULTS WERE OBTAINED FOR THREE PATIENT SAMPLES ON A DIMENSION XPAND PLUS W/ HM INSTRUMENT. TWO PATIENTS ((B)(6)) WERE ER PATIENTS DIAGNOSED WITH HYPONATREMIA. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE RERUN ON THE SAME INSTRUMENT AND RESULTED HIGHER THAN THE INITIAL RESULTS. THE RERUN RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW SODIUM RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334755 DIMENSION XPAND PLUS W/ HM CLINICAL CHEMISTRY ANALYZER JGS SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION XPAND PLUS W/ HM

    Patients

    Seq Age Sex Outcome Treatment
    1