BEUDAMED
    FDA Adverse Event Summary report: N

    ADVIA 2120I

    MDR report key: 2072595 · Received April 29, 2011

    Report

    Report Number
    2432235-2011-00060
    Date Received
    April 29, 2011
    Date of Event
    March 11, 2011
    Report Date
    March 14, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    GKL
    PMA / PMN Number
    K042251
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. THE OPERATOR WAS NOT WEARING PERSONAL PROTECTIVE EQUIPMENT AS REQUIRED BY THE SYSTEM USER GUIDE. AFTER ANALYZING THE INSTRUMENT, THE FSE FOUND THAT THE WASTE DISPOSAL SYSTEM USED BY THE CUSTOMER WAS NOT A SIEMENS APPROVED SYSTEM. PROACTIVELY, THE FSE REPLACED A CHECK VALVE AND ASKED THE CUSTOMER TO USE A NORMAL SIEMENS APPROVED WASTE CONTAINER WITH A SPIGOT. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    WASTE FLUID WAS PROJECTED ONTO THE OPERATOR'S FACE WHEN REMOVING THE WASTE BOTTLE ON AN ADVIA 2120I INSTRUMENT. THE OPERATOR WAS TREATED PREVENTIVELY. THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA 2120I HEMATOLOGY ANALYZER GKL SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 2120I N/A

    Patients

    Seq Age Sex Outcome Treatment
    1