BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 2120 WITH DAA AUTOSAMPLER

    MDR report key: 2822434 · Received November 7, 2012

    Report

    Report Number
    2432235-2012-00373
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    October 14, 2012
    Report Date
    October 14, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    GKZ
    PMA / PMN Number
    K102644
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS TECHNICAL SOLUTION CENTER (TSC) CONTACTED THE OPERATOR AND VERIFIED THAT THERE WAS NO INTERVENTION BEYOND THE ER. THE OPERATOR USED OVER-THE-COUNTER EYE DROPS FOR DRY EYES. SHE WAS FEELING WELL AND DID NOT HAVE FURTHER COMPLAINTS. THE CAUSE OF THE EVENT IS A USER ERROR: THE OPERATOR DID NOT USE GOGGLES OR A FACE SHIELD WHILE WORKING WITH THE INSTRUMENT. AS PER SIEMENS LABELING (CUSTOMER BULLETIN 10813385 REV. A, 2012-07): "ADVIA HEMATOLOGY OPERATOR'S GUIDE SAFETY PRECAUTIONS CURRENTLY STATE THAT WHEN USING OR HANDLING ADVIA EZ KLEEN / EZ WASH, BLEACH, ANY CLEANING OR ANTIVIRAL AGENT, OR ANY OTHER POTENTIALLY HAZARDOUS LIQUIDS, TO WEAR PROTECTIVE CLOTHING, GLOVES, AND SAFETY GLASSES. TO PROVIDE OPTIMAL SAFETY, SIEMENS IS NOW ALSO RECOMMENDING THE USE OF FACE SHIELDS IN ADDITION TO SAFETY GLASSES WHENEVER HANDLING POTENTIALLY HAZARDOUS MATERIALS."

    Description of Event or Problem · 1

    WHILE AN OPERATOR WAS BACK-FLUSHING THE FLOW-CELL OF AN ADVIA 2120 INSTRUMENT, THE CLEANING SYRINGE POPPED LOOSE FROM THE TUBING OF VALVE V24 AND EZ WASH SOLUTION SPLASHED INTO THE OPERATOR'S EYES. THE OPERATOR RINSED THE EYES FOR 15 MINUTES AND VISITED AN EMERGENCY ROOM (ER). ACCORDING TO THE OPERATOR, THERE WERE NO SCRATCHES, PH AND VISUAL ACUITY WERE FINE. THERE ARE NO KNOWN REPORTS OF OPERATOR INTERVENTION BEYOND THE ER OR ADVERSE HEALTH CONSEQUENCES DUE TO THE SPLASH OF EZWASH SOLUTION INTO EYES OF THE OPERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA 2120 WITH DAA AUTOSAMPLER HEMATOLOGY ANALYZER GKZ SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 2120 WITH DAA AUTOSAMPLER

    Patients

    Seq Age Sex Outcome Treatment
    1