BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABBOTT AXSYM SYSTEM

    MDR report key: 966060 · Received December 18, 2007

    Report

    Report Number
    1628664-2007-00589
    Event Type
    Other
    Date Received
    December 18, 2007
    Date of Event
    November 26, 2007
    Report Date
    November 26, 2007
    Manufacturer
    ABBOTT LABORATORIES INC
    Product Code
    JJE
    PMA / PMN Number
    L950915
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT AN INJURY OCCURRED WHILE REMOVING THE LIQUID WASTE FROM THE AXSYM ANALYZER. THE CUSTOMER PRESSED THE METAL QUICK RELEASE TAB TO REMOVE THE WASTE CONTAINER FITTINGS AND RECEIVED AN INJURY ON HER FINGER. HER FINGER BLED AND WAS CLEANED WITH DISINFECTANT AND BANDAGED. THE CUSTOMER IS AN EXPERIENCED AXSYM OPERATOR AND WEARS PERSONAL PROTECTIVE EQUIPMENT. BLOOD TESTING WAS PERFORMED ON THE CUSTOMER FOR HIV AND HEPATITIS MARKERS. NO ADD'L MEDICAL ATTENTION OR TREATMENT WAS DOCUMENTED IN THE COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT AXSYM SYSTEM AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT LABORATORIES INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR