BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACT 5DIFF WBC LYSE

    MDR report key: 2185192 · Received July 22, 2011

    Report

    Report Number
    1061932-2011-00971
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    January 21, 2010
    Report Date
    January 21, 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. ROOT CAUSE IS UNK. THE SUPPLIER WAS NOTIFIED OF THE ISSUE FOR FURTHER EVAL. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(4), 2008 AND (B)(4), 2010 OF COMPLAINTS FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    BECKMAN COULTER EMPLOYEE REPORTED A POTENTIAL CHEMICAL HAZARD WHEN TWO BOTTLES OF ACT 5DIFF WBC LYSE REAGENT WERE LEAKING. THE LEAK WAS MINIMAL, WITH LITTLE FLUID ON THE OUTSIDE OF THE BOTTLE WHEN FOUND BY THE BECKMAN COULTER WAREHOUSE EMPLOYEE. THE WORKER WAS WEARING WORK CLOTHES AND PLASTIC GLOVES. THERE WAS NO CONTACT WITH THE ACT 5DIFF WBC LYSE REAGENT. THERE WAS NO EXPOSURE TO OPEN LESIONS OR MUCOUS MEMBRANES. MEDICAL ATTENTION WAS NOT REQUIRED. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO WORKER 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 12902B

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK