BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA 1500

    MDR report key: 2905710 · Received January 9, 2013

    Report

    Report Number
    1226181-2013-00007
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 12, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    JGS
    PMA / PMN Number
    K051087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    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 POOR SAMPLE QUALITY. SIEMENS RECOMMENDED THE CUSTOMER PERFORM AN ADVANCED CLEAN, DUE TO THE HIGH AND NEGATIVE FLUID DELTAS AND TO PERFORM THE ROUTINE MAINTENANCE AS REQUIRED. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. FURTHER EVALUATION OF THE DEVICE IS NOT REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT SODIUM (NA) RESULT WAS OBTAINED ON AN DIMENSION VISTA 1500 INSTRUMENT FOR ONE PATIENT. THE RESULT WAS REPORTED TO THE PHYSICIAN. 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 NA RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11841 DIMENSION VISTA 1500 CHEMISTRY ANALYZER JGS SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION VISTA 1500

    Patients

    Seq Age Sex Outcome Treatment
    1