BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LYSE S III DIFF LYTIC REAGENT

    MDR report key: 2210136 · Received August 5, 2011

    Report

    Report Number
    1061932-2011-01063
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    February 22, 2010
    Report Date
    March 1, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GGK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS REPLACED AT THE TIME OF EVENT. PRODUCT WAS NOT RETURNED FOR EVAL. BASED UPON AVAILABLE INFO ROOT CAUSE IS UNK. A REVIEW FOR SIMILAR EVENTS WAS CONDUCTED. FROM 2005-2010, THERE HAVE BEEN NO SIMILAR REPORTS OF LEAKING FROM THE CONTAINER WITH THIS REAGENT. 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 USING THE COULTER LYSE S III DIFF LYTIC REAGENT. THE OPERATOR WAS SECURING THE PICKUP TUBING ONTO THE COULTER LYSE S III DIFF LYTIC REAGENT CONTAINER WHEN APPROX 5 ML OF REAGENT LEAKED OUT FROM THE CONTAINER CAP. THE LEAK OCCURRED WHEN PRESSURE WAS APPLIED TO THE CONTAINER. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE). THERE WAS NO EXPOSURE TO MUCOUS MEMBRANES, OPEN LESIONS, SKIN OR EYES. MEDICAL TREATMENT 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 COULTER LYSE S III DIFF LYTIC REAGENT GGK BECKMAN COULTER, INC. NA 101665F

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK COULTER LH 750 HEMATOLOGY ANALYZER