BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACT 5DIFF WBC LYSE

    MDR report key: 2185207 · Received July 22, 2011

    Report

    Report Number
    1061932-2011-00950
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    January 15, 2010
    Report Date
    January 15, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GGK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAKING BOTTLES OF ACT 5DIFF WBC LYSE WERE DISCARDED BY THE CUSTOMER. THE PRODUCT WAS REPLACED FOR THE CUSTOMER. ROOT CAUSE IS UNK. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(4) 2008 AND (B)(4) 2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A POTENTIAL CHEMICAL EXPOSURE WHEN A SHIPMENT OF ACT 5DIFF WBC LYSE REAGENT WAS RECEIVED DAMAGED AND LEAKING. THE OPERATORS WERE NOT EXPOSED TO THE ACT 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. THE CUSTOMER HAS AN EXPOSURE PLAN IN PLACE WITHIN THE LAB. 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 13202B07123

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK COULTER ACT 5DIFF CAP PIERCE (CP)