BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA 500

    MDR report key: 3961590 · Received July 28, 2014

    Report

    Report Number
    1226181-2014-00401
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 3, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    JJE
    PMA / PMN Number
    K051087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE CSE EVALUATED THE INSTRUMENT AND INSTRUMENT DATA AND REPLACED SYSTEM PROBES AND PERFORMED ALIGNMENTS. THE CSE ALSO CLEANED THE INTEGRATED MULTISENSOR TECHNOLOGY (IMT) MODULE AND DRAINS. THE CAUSE OF THE DISCORDANT SODIUM, POTASSIUM AND UREA NITROGEN RESULTS IS UNKNOWN. THE CSE SUCCESSFULLY RAN QUALITY CONTROLS. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. FURTHER EVALUATION OF THE DEVICE IS NOT REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT SODIUM (NA), POTASSIUM (K) AND UREA NITROGEN (BUN) RESULTS WERE OBTAINED ON ONE PATIENT SAMPLE ON A DIMENSION VISTA 500 INSTRUMENT. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON AN ALTERNATE INSTRUMENT. THE REPEAT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT NA, K AND BUN RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439714 DIMENSION VISTA 500 CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION VISTA 500

    Patients

    Seq Age Sex Outcome Treatment
    1