BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA® CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2912318 · Received January 11, 2013

    Report

    Report Number
    1226181-2013-00022
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 17, 2012
    Report Date
    December 18, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    LEH
    PMA / PMN Number
    K051087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 PROBE ALIGNMENT. THE FSE PERFORMED MAINTENANCE AND PRIMED, CLEANED AND ALIGNED THE PROBE. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT VANCOMYCIN RESULT WAS OBTAINED ON THE VISTA 500 INSTRUMENT. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAMPLE WAS RE-TESTED ON THE SAME INSTRUMENT AND ON A DIMENSION XPAND INSTRUMENT AND THE CORRECTED VANCOMYCIN RESULT WAS REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT VANCOMYCIN RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18996 DIMENSION VISTA® CLINICAL CHEMISTRY SYSTEM CLINICAL CHEMISTRY SYSTEM LEH SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW VISTA 500

    Patients

    Seq Age Sex Outcome Treatment
    1