BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION XPAND PLUS WITH HM

    MDR report key: 3923612 · Received July 9, 2014

    Report

    Report Number
    1226181-2014-00356
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 15, 2014
    Report Date
    June 16, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    JJE
    PMA / PMN Number
    K112999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS TECHNICAL SOLUTIONS CENTER (TSC). AFTER EVALUATION OF INSTRUMENT DATA, TSC DID NOT FIND AN INSTRUMENT MALFUNCTION. IT WAS DISCOVERED THAT THE CUSTOMER WAS CENTRIFUGING PATIENT SAMPLES OUTSIDE OF THE TUBE MANUFACTURER SPECIFICATIONS. THE CAUSE OF DISCORDANT NA RESULTS IS UNKNOWN. THE CAUSE OF THE SAMPLE BEING CENTRIFUGED OUTSIDE OF TUBE VENDOR SPECIFICATIONS IS FAILURE TO FOLLOW INSTRUCTIONS. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT SODIUM (NA) RESULTS WERE OBTAINED ON PATIENT SAMPLES ON A DIMENSION XPAND PLUS WITH HM INSTRUMENT. THE DISCORDANT RESULTS OF SOME PATIENTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THEM. THE SAMPLES WERE REPEATED ON AN ALTERNATE INSTRUMENT, RESULTING LOWER FOR ALL BUT ONE SAMPLE. THE CORRECTED RESULTS OF SOME PATIENTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT NA RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399887 DIMENSION XPAND PLUS WITH HM CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION XPAND PLUS WITH HM

    Patients

    Seq Age Sex Outcome Treatment
    1