BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION® XPAND PLUS WITH HM

    MDR report key: 2912326 · Received January 11, 2013

    Report

    Report Number
    1226181-2013-00016
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 13, 2012
    Report Date
    December 13, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC- BROOKFIELD
    Product Code
    JGS
    PMA / PMN Number
    K010061
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SIEMENS TECHNICAL SUPPORT CENTER (TSC) ANALYZED THE INSTRUMENT DATA AND DETERMINED THE CAUSE OF THE DISCORDANT SODIUM RESULTS WERE DUE TO POOR SAMPLE QUALITY. THE TSC DETERMINED THAT THE CUSTOMER WAS USING A SWINGING BUCKET CENTRIFUGE AND SPINNING FOR 6 MINUTES VERSUS THE TUBE VENDOR RECOMMENDED 10 MINUTES. SIEMENS RECOMMENDED THE CUSTOMER FOLLOW THE TUBE MANUFACTURER'S RECOMMENDATIONS FOR PROPER CENTRIFUGATION TIMES AND SPEED. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. FURTHER EVALUATION OF THE DEVICE IS NOT REQUIRED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT TWO (2) DISCORDANT HIGH SODIUM (NA) RESULTS WERE OBTAINED FROM THE DIMENSION XPAND PLUS WITH HM SYSTEM. THE SAMPLES WERE RETESTED ON THE SAME INSTRUMENT. THE INITIAL DISCORDANT RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES OR KNOWN PATIENT INTERVENTION DUE TO THE DISCORDANT SODIUM RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16352 DIMENSION® XPAND PLUS WITH HM CLINICAL CHEMISTRY SYSTEM JGS SIEMENS HEALTHCARE DIAGNOSTICS INC- BROOKFIELD DIMENSION® XPAND PLUS WITH HM

    Patients

    Seq Age Sex Outcome Treatment
    1