BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACT 5DIFF WBC LYSE

    MDR report key: 2185190 · Received July 22, 2011

    Report

    Report Number
    1061932-2011-00964
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    January 20, 2010
    Report Date
    January 20, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GGK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DISCARDED THE LEAKING REAGENT BOTTLES AND WERE NOT RETURNED FOR EVAL. ROOT CAUSE IS UNK. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN 01/01/2008 AND 10/23/2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A POTENTIAL CHEMICAL HAZARD WHEN A SHIPMENT OF ACT 5DIFF WBC LYSE REAGENT WAS RECEIVED PARTIALLY FROZEN AND LEAKING FROM THE CAP AREA. THE LEAK WAS SMALL, LESS THAN 5 ML. THE OPERATORS WERE NOT EXPOSED TO THE REAGENT. THERE WAS NO EXPOSURE TO OPEN LESIONS, MUCUS MEMBRANES, OR ANY CONTACT TO EYES OR SKIN. THE OPERATOR WAS WEARING PROPER PERSONAL PROTECTIVE EQUIPMENT OF LAB COAT AND GLOVES. MEDICAL ATTENTION WAS NOT REQUIRED. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO OPERATOR SAFETY AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACT 5DIFF WBC LYSE GGK BECKMAN COULTER, INC. NA 13202B00665

    Patients

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