BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA 1500

    MDR report key: 3090858 · Received May 2, 2013

    Report

    Report Number
    1226181-2013-00198
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 5, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    JJE
    PMA / PMN Number
    K051087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SIEMENS TECHNICAL SUPPORT CENTER (TSC) ANALYZED THE INSTRUMENT DATA AND DETERMINED THE CAUSE OF THE DISCORDANT SODIUM RESULT WAS DUE TO USER ERROR; SHORT SAMPLE. SIEMENS RECOMMENDED THAT THE CUSTOMER REPEAT THE SAMPLE. THE TSC DETERMINED THAT THERE WAS NO MALFUNCTION OR INSTRUMENT ISSUE DURING THE TIME OF THE EVENT. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. FURTHER EVALUATION OF THE DEVICE IS NOT REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT UREA NITROGEN (BUN) RESULT WAS OBTAINED ON AN DIMENSION VISTA 1500 INSTRUMENT FOR ONE PATIENT. THE CUSTOMER REPEATED THE SAMPLE FROM THIS PATIENT ON THE SAME INSTRUMENT AFTER THE PHYSICIAN QUESTIONED THE RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT BUN RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191785 DIMENSION VISTA 1500 CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION VISTA 1500

    Patients

    Seq Age Sex Outcome Treatment
    1