BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    A.T 5DIFF WBC LYSE

    MDR report key: 2229255 · Received August 12, 2011

    Report

    Report Number
    1061932-2011-01138
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    March 17, 2010
    Report Date
    March 29, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GGK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAKING BOTTLES OF A.T 5DIFF WBC LYSE WERE DISCARDED BY THE CUSTOMER. THE PRODUCT WAS REPLACED FOR THE CUSTOMER. ROOT CAUSE IS UNK. THE SUPPLIER WAS NOTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN JANUARY 1, 2008 AND OCTOBER 23, 2010 OF COMPLAINTS FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A POTENTIAL CHEMICAL EXPOSURE WHEN A SHIPMENT OF A.T 5 DIFF WBC LYSE REAGENT WAS RECEIVED LEAKING. THE SHIPPING CONTAINER WAS NOT DAMAGED. THE OPERATORS WERE NOT EXPOSED TO THE A.T 5DIFF WBC LYSE 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. NO ONE SOUGHT MEDICAL ATTENTION AND THE PRODUCT MATERIAL SAFETY DATA SHEET WAS REVIEWED. 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 A.T 5DIFF WBC LYSE GGK BECKMAN COULTER, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK COULTER A.T 5DIFF CAP PIERCE (CP)