BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION XPAND PLUS WITH HM

    MDR report key: 4801991 · Received May 28, 2015

    Report

    Report Number
    1226181-2015-00343
    Event Type
    Malfunction
    Date Received
    May 28, 2015
    Date of Event
    April 19, 2015
    Report Date
    May 3, 2015
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    JJE
    PMA / PMN Number
    K112999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC). THE CUSTOMER STATED THAT AFTER THE PATIENT SAMPLE WAS RUN, THERE WERE NO ADDITIONAL DISCORDANT RESULTS. CCC INSTRUCTED THE CUSTOMER TO RUN QUALITY CONTROLS, WHICH RESULTED WITHIN RANGE. THE CUSTOMER ALSO ADJUSTED THE PUMP RATE. THE CAUSE OF THE DISCORDANT SODIUM RESULT IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT, FALSELY LOW SODIUM (NA) RESULT WAS OBTAINED ON ONE PATIENT SAMPLE ON A DIMENSION XPAND PLUS WITH HM INSTRUMENT. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S).THE SAMPLE WAS REPEATED ON THE SAME INSTRUMENT, RESULTING HIGHER. IT IS UNKNOWN IF THE CORRECTED RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW NA RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347031 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