BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOMATE 2500 SAMPLE PROCESSING SYSTEM

    MDR report key: 2802025 · Received October 23, 2012

    Report

    Report Number
    2050012-2012-01782
    Event Type
    Injury
    Date Received
    October 23, 2012
    Date of Event
    September 28, 2012
    Report Date
    October 1, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JQP
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT SHE GOT A CUT ON HER FINGER WHILE TRYING TO CLEAN THE METAL PLATE IN THE WASTE BOX ON AUTOMATE 2500 SAMPLE PROCESSING SYSTEM. THE METAL PLATE IS SOFT, SO THE CUSTUMER SLIPPED WITH HER HAND BETWEEN THE METAL PLATE AND THE BOTTOM PLATE. SHE HAD A BIG CUT ON THE LITTLE FINGER ON THE LEFT HAND AND HAD A HEAVY BLEEDING. THE CUSTOMER IMMEDIATELY SOUGHT A MEDICAL ATTENTION, AND THE CUT WAS SEWN WITH SEVERAL TUCKS. BLOOD TEST WAS NOT PERFORMED AS SHE SAID THE UNIT WAS NEW AND NOT DIRTY. THE CUSTOMER WAS SIGNED OFF SICK FOR TWO WEEKS BUT IS NOW WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATE 2500 SAMPLE PROCESSING SYSTEM CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE JQP BECKMAN COULTER, INC. AUTOMATE 2500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention