BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER ACT 5DIFF WBC LYSE

    MDR report key: 1941259 · Received December 29, 2010

    Report

    Report Number
    1061932-2010-00317
    Event Type
    Malfunction
    Date Received
    December 29, 2010
    Date of Event
    December 2, 2010
    Report Date
    December 2, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GGK
    PMA / PMN Number
    CLASSIEXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS PROVIDED WITH A REPLACEMENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT A COULTER ACT 5 DIFF WBC LYSE BOTTLE WAS RECEIVED LEAKING. THE CUSTOMER INDICATED THAT AFTER OPENING THE PRODUCT'S PACKAGE, THE INSIDE OF THE BOX WAS NOTICED SLIGHTLY WET. NO "SPILLAGE" WAS NOTED. THE CUSTOMER WAS WEARING PROPER PPE AND THERE WAS NO REAGENT EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. THERE WAS NO INJURY REPORTED AS A RESULT OF THIS EVENT AND MEDICAL ATTENTION WAS NOT NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER ACT 5DIFF WBC LYSE WBC LYSE REAGENT GGK BECKMAN COULTER INC. NA 14502B03317

    Patients

    Seq Age Sex Outcome Treatment
    1