BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA 500

    MDR report key: 3212391 · Received July 9, 2013

    Report

    Report Number
    1226181-2013-00305
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 11, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    NGS
    PMA / PMN Number
    K051087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 DISCOVERED THE INTEGRATED MULTISENSOR TECHNOLOGY (IMT) AND IMT PROBE WERE MISALIGNED AND INSTRUCTED THE CUSTOMER TO ALIGN IT. ONCE ALIGNED, QUALITY CONTROLS WERE RUN AND WITHIN RANGE. THE CAUSE OF THE DISCORDANT, FALSELY LOW SODIUM RESULTS IS DUE TO THE MISALIGNMENT OF THE IMT AND IMT PROBE. 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 ONE PATIENT SAMPLE ON A DIMENSION VISTA 500 INSTRUMENT. THE SAMPLE WAS RUN IN DUPLICATE AND BOTH RESULTED LOW. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS THEN RERUN FOUR TIMES ON ANOTHER ANALYZER AND ALL 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
    313312 DIMENSION VISTA 500 CLINICAL CHEMISTRY ANALYZER NGS SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA 500

    Patients

    Seq Age Sex Outcome Treatment
    1