BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACT 5 DIFF FIX

    MDR report key: 2211530 · Received August 5, 2011

    Report

    Report Number
    1061932-2011-01067
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    March 3, 2010
    Report Date
    March 3, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GGK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS NOT RETURNED FOR EVAL. PHOTOGRAPHIC IMAGES WERE SENT. THE PHOTOGRAPH DEMONSTRATED INDENTATION DAMAGE TO THE BOTTOM OF ONE OF THE CONTAINERS. ROOT CAUSE IS UNK. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(6) 2008 AND (B)(6) 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    BECKMAN COULTER, INC. EMPLOYEE REPORTED A POTENTIAL CHEMICAL EXPOSURE WHEN APPROX 20ML OF FLUID LEAKED FROM A CONTAINER OF ACT 5 DIFF FIX REAGENT AND TWO CONTAINERS SHOWED EVIDENCE OF MOISTURE. THE WAREHOUSE EMPLOYEE WAS WEARING GLOVES AND WORK CLOTHES AT THE TIME OF THE INCIDENT. THERE WAS NO CONTACT WITH MUCOUS MEMBRANES OR OPEN WOUNDS. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO OPERATOR SAFETY TREATMENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACT 5 DIFF FIX GGK BECKMAN COULTER, INC. NA 14802E

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK COULTER ACT 5DIFF HEMATOLOGY ANALYZER