BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT 5DDIFF WBC LYSE

    MDR report key: 1890372 · Received November 3, 2010

    Report

    Report Number
    1061932-2010-00201
    Event Type
    Malfunction
    Date Received
    November 3, 2010
    Date of Event
    October 11, 2010
    Report Date
    November 3, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GGK
    PMA / PMN Number
    CL1-EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MSDS WAS NOT REVIEWED BUT RISK MANAGEMENT PLAN IS IN PLACE FOR THIS FACILITY. NO DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    A BECKMAN COULTER INC. (BCI) WAREHOUSE OPERATOR REPORTED THAT AN ACT 5DIFF WBC LYSE REAGENT BOTTLE WAS DAMAGED AND LEAKING. THE OUTER PACKAGING DID NOT APPEAR DAMAGED WHEN RECEIVED. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE), AND THERE WAS NO EXPOSURE OF THE REAGENT TO EYES, MOUTH, OR OPEN WOUNDS. NO DEATH OR INJURY WAS REPORTED FOR THIS EVENT. NO ONE SOUGHT MEDICAL ATTENTION. THERE WAS NO EFFECT TO PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® ACT 5DDIFF WBC LYSE BLOOD CELL LYSING REAGENT GGK BECKMAN COULTER, INC. NA 14102B

    Patients

    Seq Age Sex Outcome Treatment
    1