BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® 4C® PLUS CELL CONTROL

    MDR report key: 2072833 · Received April 29, 2011

    Report

    Report Number
    1061932-2011-00327
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    March 30, 2011
    Report Date
    March 31, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JPK
    PMA / PMN Number
    K955016
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED. A COURTESY REPLACEMENT WAS SENT TO THE CUSTOMER. AT THIS TIME, THE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. PER MSDS LABELING: THIS PRODUCT SHOULD BE HANDLED AS THOUGH CAPABLE OF TRANSMITTING INFECTIOUS DISEASE. UNIVERSAL PRECAUTIONS SHOULD BE FOLLOWED WHEN USING THIS PRODUCT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THEIR COULTER 4C PLUS CONTROL VIAL WAS FOUND CRACKED. CONTROLS WERE NOT LEAKING WHEN REMOVED FROM THE REFRIGERATOR. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE). NO REPORTS OF EXPOSURE TO OR CONTACT WITH EYES OR SKIN, MUCOUS MEMBRANES OR OPEN WOUNDS. NO DEATH OR SERIOUS INJURY HAVE BEEN REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® 4C® PLUS CELL CONTROL HEMATOLOGY QUALITY CONTROL MIXTURE JPK BECKMAN COULTER INC. N/A 1000391K

    Patients

    Seq Age Sex Outcome Treatment
    1