BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® 4C® PLUS CELL CONTROL

    MDR report key: 2092665 · Received May 18, 2011

    Report

    Report Number
    1061932-2011-00418
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 18, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JPK
    PMA / PMN Number
    K955016
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE OPERATOR WAS PROVIDED WITH A REPLACEMENT. AT THIS TIME, THE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. PER LABELING, THIS SPECIMEN/REAGENT SHOULD BE HANDLED AT BIOSAFETY LEVEL 2, AS RECOMMENDED FOR ANY POTENTIALLY INFECTIOUS HUMAN SERUM OR BLOOD SPECIMEN IN THE CENTERS FOR DISEASE CONTROL/NATIONAL INSTITUTES OF HEALTH MANUAL "BIOSAFETY IN MICROBIOLOGICAL AND BIOMEDICAL LABORATORIES," 1988.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BCI) STATING THAT THEIR COULTER 4C PLUS CELL CONTROL VIAL WAS CRACKED WHEN RECEIVED. THE LEAKAGE WAS CONTAINED WITHIN THE PACKAGING. THE CONTROL VIAL WAS NOT RUN ON THE INSTRUMENT. THE CUSTOMER WAS WEARING GLOVES WHEN HANDLING THE CONTROL MATERIAL. NO EXPOSURE OCCURRED TO MUCOUS MEMBRANES OR OPEN WOUNDS. NO DEATH, SERIOUS INJURY, OR AFFECT TO USER 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. NA 085700

    Patients

    Seq Age Sex Outcome Treatment
    1