BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DXH CELL LYSE

    MDR report key: 2468689 · Received February 26, 2012

    Report

    Report Number
    1061932-2012-00606
    Event Type
    Malfunction
    Date Received
    February 26, 2012
    Date of Event
    February 1, 2012
    Report Date
    February 1, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GGK
    PMA / PMN Number
    CLASS I EXEM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THEY RECEIVED A BOTTLE OF AC T 5 DIFF WBC LYSE THAT WAS LEAKING DUE TO A LOOSE CAP. THERE WAS NO REPORT OF PATIENT RESULTS AFFECTED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DXH CELL LYSE PRODUCTS, RED-CELL LYSING PRODUCTS GGK BECKMAN COULTER, INC. 16202B

    Patients

    Seq Age Sex Outcome Treatment
    1