BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA 500

    MDR report key: 4103730 · Received September 19, 2014

    Report

    Report Number
    1226181-2014-00472
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 27, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    JJE
    PMA / PMN Number
    K051087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 CLEANED THE REAGENT 1 PROBE, INTEGRATED MULTISENSOR TECHNOLOGY MODULE AND ALIQUOT DRAINS. THE CSE ALSO VERIFIED PROBE ALIGNMENTS. THE CAUSE OF THE DISCORDANT CREATININE, UREA NITROGEN, POTASSIUM AND TOTAL BILIRUBIN RESULTS IS UNKNOWN. THE CSE SUCCESSFULLY RAN A SYSTEM CHECK AND QUALITY CONTROLS. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. FURTHER EVALUATION OF THE DEVICE IS NOT REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT CREATININE (CREA), UREA NITROGEN (BUN), POTASSIUM (K) AND TOTAL BILIRUBIN (TBIL) RESULTS WERE OBTAINED ON ONE EMERGENCY ROOM PATIENT ON A DIMENSION VISTA 500 INSTRUMENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO ADMITTED THE PATIENT FOR OBSERVATION. THE PATIENT WAS REDRAWN AND THE SAMPLE WAS TESTED ON AN ALTERNATE SYSTEM. THE CORRECTED RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CREA, BUN, K AND TBIL RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582336 DIMENSION VISTA 500 CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION VISTA 500

    Patients

    Seq Age Sex Outcome Treatment
    1