BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA® CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2842762 · Received November 21, 2012

    Report

    Report Number
    1226181-2012-00130
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 29, 2012
    Report Date
    October 29, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    LEH
    PMA / PMN Number
    K051087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO EVALUATE THE VISTA 500 INSTRUMENT. AFTER ANALYZING THE INSTRUMENT AND INSTRUMENT DATA, THE FSE DETERMINED THAT THE CAUSE OF THE DISCORDANT RESULTS WAS WEAK MIXING WITH THE R2 PROBE AND PROBE ALIGNMENT. THE FSE PERFORMED MAINTENANCE AND ALIGNED THE PROBE. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    MULTIPLE DISCORDANT VANCOMYCIN RESULTS WERE OBTAINED ON THE VISTA 500 INSTRUMENT. THE SAMPLES WERE RE-TESTED AND THE CORRECTED VANCOMYCIN RESULTS WERE REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT VANCOMYCIN RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIMENSION VISTA® CLINICAL CHEMISTRY SYSTEM CLINICAL CHEMISTRY SYSTEM LEH SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW VISTA 500

    Patients

    Seq Age Sex Outcome Treatment
    1