BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT DIFF 2 ANALYZER

    MDR report key: 1971914 · Received January 27, 2011

    Report

    Report Number
    1061932-2011-00041
    Event Type
    Malfunction
    Date Received
    January 27, 2011
    Date of Event
    December 30, 2010
    Report Date
    December 30, 2010
    Manufacturer
    BECKMAN COULTER INC
    Product Code
    GKZ
    PMA / PMN Number
    K955016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPLACEMENT WAS SENT TO THE CUSTOMER. A CLEAR ROOT CAUSE FOR THE LEAK IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT A WAREHOUSE PERSONNEL RECEIVED COULTER DIFF ACT TAINER REAGENT KIT AND REAGENT 2 COULTER LYTIC REAGENT THAT WERE DAMAGED AND LEAKED. NO INJURY OR EXPOSURE/CONTACT TO EYE, SKIN, OPEN WOUNDS, OR MUCUS MEMBRANE HAD OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® ACT DIFF 2 ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER INC ACT DIFF 2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1