BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMUNOPREPTM REAGENT A 300 TEST

    MDR report key: 2228050 · Received August 30, 2011

    Report

    Report Number
    1061932-2011-01293
    Event Type
    Malfunction
    Date Received
    August 30, 2011
    Date of Event
    July 25, 2011
    Report Date
    July 25, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GGK
    PMA / PMN Number
    CLASS1EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEFECTIVE IMMUNOPREP REAGENT KIT WAS REPLACED.(B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REPORTING THAT WHEN THE ORDER OF IMMUNOPREP REAGENT A WAS RECEIVED, THE REAGENT BOTTLE HAD LEAKED (IMMUNOPREP REAGENT A IS A COLORLESS, CLEAR, ODORLESS, NONFLAMMABLE ACQUEOUS SOLUTION. EXPOSURE MAY RESULT IN IRRITATION OF SKIN, EYES AND MUCOUS MEMBRANES). NO INJURY OR EXPOSURE WAS REPORTED AND MEDICAL ATTENTION WAS NOT SOUGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMUNOPREPTM REAGENT A 300 TEST RED-CELL LYSING PRODUCT GGK BECKMAN COULTER INC. NA 1099054K

    Patients

    Seq Age Sex Outcome Treatment
    1