BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA 500

    MDR report key: 3022228 · Received March 26, 2013

    Report

    Report Number
    1226181-2013-00145
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    February 27, 2013
    Report Date
    February 27, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    JJE
    PMA / PMN Number
    K051087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE ANALYZED THE INSTRUMENT AND DETERMINED THE CAUSE FOR THE DISCORDANT CALCIUM AND POTASSIUM RESULTS WAS UNKNOWN. THE FSE REPLACED THE SERVER 1 PROBE, ALIQUOT PROBE AND SERVER 1 MIXER. ALL THE METHODS AND QUALITY CONTROL WERE WITHIN SPECIFICATIONS. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. FURTHER EVALUATION OF THE DEVICE IS NOT REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT CALCIUM (CA) AND POTASSIUM (K) RESULTS WERE OBTAINED ON A DIMENSION VISTA 500 INSTRUMENT. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN. THE CUSTOMER RERAN THE SAME SAMPLE ON THE SAME INSTRUMENT AND THE CORRECTED RESULTS WERE REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CA AND K RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124041 DIMENSION VISTA 500 CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION VISTA 500

    Patients

    Seq Age Sex Outcome Treatment
    1