BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA® CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2950461 · Received February 8, 2013

    Report

    Report Number
    1226181-2013-00073
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 6, 2013
    Report Date
    January 15, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - BROOKFIELD
    Product Code
    JJE
    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 (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER ANALYSIS OF THE INSTRUMENT, INSTRUMENT DATA AND SAMPLES, THE FSE DETERMINED THAT THE CAUSE OF THE INCORRECT PATIENT INFORMATION DISPLAY WAS OPERATOR INPUT ERROR. THE PATIENT DEMOGRAPHIC INFORMATION WAS INCORRECTLY INPUT TO THE VISTA 1500 ORDER ENTRY SCREEN. THE VISTA 1500 INSTRUMENT AND SYNGO SOFTWARE ARE PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    AN OPERATOR ACCESSED THE VISTA 1500 USER INTERFACE AND INPUT PATIENT IDENTIFIER (PID) INFORMATION INTO THE INCORRECT INPUT FIELD. THE OPERATOR INPUT THE PID INFORMATION INTO THE SAMPLE LOCATION FIELD. AS A CONSEQUENCE, PATIENT DEMOGRAPHIC INFORMATION WAS NOT CORRECTLY PRESENTED AT THE SYNGO INTERFACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53695 DIMENSION VISTA® CLINICAL CHEMISTRY SYSTEM CLINICAL CHEMISTRY SYSTEM JJE SIEMENS HEALTHCARE DIAGNOSTICS INC - BROOKFIELD VISTA 1500

    Patients

    Seq Age Sex Outcome Treatment
    1