BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMUNOPREP REAGENT

    MDR report key: 2242678 · Received September 10, 2011

    Report

    Report Number
    1061932-2011-01407
    Event Type
    Malfunction
    Date Received
    September 10, 2011
    Date of Event
    August 11, 2011
    Report Date
    August 11, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GGK
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PER LABELING, WARNINGS: #9. MAY CAUSE SENSITIZATION BY SKIN CONTACT. #11. WEAR SUITABLE PROTECTIVE CLOTHING, GLOVES AND EYE/FACE PROTECTION. #12. IN CASE OF ACCIDENT OR IF YOU FEEL UNWELL, SEEK MEDICAL ADVICE IMMEDIATELY. (B)(4).

    Description of Event or Problem · 1

    A BECKMAN COULTER EMPLOYEE FROM A FACILITY IN (B)(6) REPORTED RECEIVING IMMUNOPREP REAGENT THAT WAS LEAKING DUE TO LOOSE CAPS. FROM THE PICTURES ATTACHED TO THE COMPLAINT, THE COMPONENT THAT LEAKED WAS REAGENT A. THE REPORTER OF THE INCIDENT REPORTED WEARING GLOVES AFTER THE LEAK WAS FOUND. THERE WAS NO EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. MEDICAL ATTENTION WAS NOT SOUGHT. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT AS A RESULT OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMUNOPREP REAGENT RED CELL LYSING REAGENT GGK BECKMAN COULTER, INC. 1099055K

    Patients

    Seq Age Sex Outcome Treatment
    1