BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMUNOPREP REAGENT SYSTEM, 300 TEST

    MDR report key: 2148254 · Received July 2, 2011

    Report

    Report Number
    1061932-2011-00825
    Event Type
    Malfunction
    Date Received
    July 2, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 2, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GGK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE FOR THIS EVENT IS DAMAGE TO THE PACKAGE DURING SHIPPING.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC (BEC) THAT A SHIPMENT OF IMMUNOPREP REAGENT ARRIVED DAMAGED AND THE REAGENT WAS LEAKING FROM ALL THREE REAGENTS IN THE KIT. THE INCIDENT OCCURRED IN A BECKMAN COULTER WAREHOUSE. THE OPERATOR WAS WEARING LAB COAT, GOGGLES, AND GLOVES WHEN HANDLING THE DAMAGED CONTAINERS. THERE WAS NO EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION. THE MSDS WAS REVIEWED AND THERE IS AN EXPOSURE CONTROL PLAN IN PLACE AT THE FACILITY. NO DEATH OR INJURY OCCURRED AS A RESULT OF THIS INCIDENT AND THERE WAS NO CHANGE TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMUNOPREP REAGENT SYSTEM, 300 TEST RED-CELL LYSING PRODUCTS GGK BECKMAN COULTER, INC. NA 1099052K

    Patients

    Seq Age Sex Outcome Treatment
    1