BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER AC.T 5DIFF FIX

    MDR report key: 2403000 · Received January 7, 2012

    Report

    Report Number
    1061932-2012-00057
    Event Type
    Malfunction
    Date Received
    January 7, 2012
    Date of Event
    December 8, 2011
    Report Date
    December 8, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BECKMAN COULTER, INC. IDENTIFIER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    A BECKMAN COULTER, INC. EMPLOYEE CALLED TO REPORT THAT A BOTTLE OF COULTER AC.T 5DIFF FIX REAGENT WAS FOUND TO BE LEAKING FROM THE TOP OF THE BOTTLE UPON ARRIVAL TO THE BECKMAN COULTER, INC. (B)(4). PERSONNEL WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF ONLY GLOVES WHEN THE INCIDENT OCCURRED. NO INJURIES OCCURRED AND NO-ONE SOUGHT MEDICAL ATTENTION. THERE WAS NO REPORT OF EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS THERE IS NO EXPOSURE/RISK MANAGEMENT PLAN IN PLACE AT THE FACILITY; HOWEVER THE MATERIAL SAFETY DATA SHEET (MSDS) WAS REVIEWED AT THE TIME OF THE INCIDENT. BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE LEAK WAS DUE TO A GAP/HOLE AT THE TOP OF THE REAGENT BOTTLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER AC.T 5DIFF FIX COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. AC.T 5DIFF FIX, 1L 17702E

    Patients

    Seq Age Sex Outcome Treatment
    1