BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LYSE S III DIFF LYTIC REAGENT

    MDR report key: 2110105 · Received June 1, 2011

    Report

    Report Number
    1061932-2011-00522
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 2, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GGK
    PMA / PMN Number
    CL I EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS SENT REPLACEMENT REAGENT. THE ROOT CAUSE FOR THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) AND REPORTED THAT COULTER® LYSE S III DIFF LYTIC REAGENT WAS RECEIVED LEAKING FROM A CRUSHED CONTAINER. THE CONTAINER'S OUTER BOX WAS DISCARDED AND IT IS UNKNOWN IF THE INCIDENT OCCURRED DURING SHIPPING. THE PERSON RECEIVED THE REAGENT WAS WEARING PERSONAL PROTECTIVE EQUIPMENT. NO INJURIES OCCURRED AND MEDICAL ATTENTION WAS NOT SOUGHT. THERE WAS NO REPORT OF EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. THE FACILITY HAS AN EXPOSURE PLAN. MSDS WAS NOT REVIEWED BUT READILY AVAILABLE. THERE WAS NO REPORT OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LYSE S III DIFF LYTIC REAGENT HEMATOLOGY LYSING REAGENT GGK BECKMAN COULTER, INC. NA 101589F

    Patients

    Seq Age Sex Outcome Treatment
    1