BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 2120I WITH AUTOSAMPLER

    MDR report key: 2874328 · Received December 14, 2012

    Report

    Report Number
    2432235-2012-00435
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    November 21, 2012
    Report Date
    November 21, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K042251
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT AT THE TIME OF THE EVENT. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    INTERNATIONAL CUSTOMER REPORTED TO SIEMENS HEALTHCARE INC THAT SHE SUSTAINED A NEEDLE STICK TO HER FINGER FROM THE AUTOMATIC CLOSED TUBE SAMPLING NEEDLE WHILE ATTEMPTING TO UNBLOCK THE AUTOSAMPLER ARM OF THE ADVIA 2120I WITH AUTOSAMPLER. THE SYSTEM OPERATOR CLEANED AND DISINFECTED THE WOUND. THE OPERATOR THEN REGISTERED THE EVENT WITH THE FACILITY HEALTH DEPARTMENT AND WAS PLACED INTO AN INTERNAL PROTOCOL FOR ACCIDENTS WITH BIOLOGICAL RISKS. THE OPERATOR DID NOT GO TO THE EMERGENCY ROOM. THE OPERATOR DID NOT RECEIVE ANY ANTIVIRAL THERAPY OR OTHER MEDICAL INTERVENTION. THE OPERATOR IS REPORTED AS WELL AND WORKING NORMALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA 2120I WITH AUTOSAMPLER IMMUNOASSAY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 2120I NA

    Patients

    Seq Age Sex Outcome Treatment
    1