BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACT 5DIFF WBC LYSE

    MDR report key: 2188427 · Received July 29, 2011

    Report

    Report Number
    1061932-2011-01028
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Date of Event
    February 4, 2010
    Report Date
    February 5, 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 CUSTOMER USED LAB PROTOCOL TO CLEAN THE BOTTLES FOR USE. THE PRODUCT WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE IS UNK. THE SUPPLIER WAS NOTIFIED OF THE ISSUE FOR FURTHER EVALUATION. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN 01/01/2008 AND 10/23/2010 OF COMPLAINTS FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A POTENTIAL CHEMICAL HAZARD WHEN ACT 5DIFF WBC LYSE REAGENT LEAKED. A SMALL AMOUNT HAD LEAKED FROM THE CAP AND ONTO THE SIDE OF THE BOTTLES. THERE WAS NO EXPOSURE TO THE ACT 5DIFF WBC LYSE REAGENT. THERE WAS NO EXPOSURE TO OPEN LESIONS OR MUCUS MEMBRANES. OPERATORS WERE WEARING APPROPRIATE 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 13202B

    Patients

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