BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMUNO-PREP REAGENT SYSTEM

    MDR report key: 2449367 · Received February 14, 2012

    Report

    Report Number
    1061932-2012-00505
    Event Type
    Malfunction
    Date Received
    February 14, 2012
    Date of Event
    January 18, 2012
    Report Date
    January 18, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GGK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BECKMAN COULTER, INC. IDENTIFIER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    A BECKMAN COULTER, INC. (BEC) EMPLOYEE REPORTED THAT BOTTLE A OF THE IMMUNO-PREP REAGENT SYSTEM REAGENT (300 TEST KIT), LOT #1099062K, LEAKED. THE BEC EMPLOYEE REPORTED THAT THERE WAS NEITHER SLACK OF CAP NOR BREAKAGE OF BOTTLE, AND THAT THE PACKAGE WAS INTACT. NO SERVICE REQUEST WAS MADE SINCE THIS WAS AN INTERNAL COMPLAINT FROM A BEC EMPLOYEE. THE ROOT CAUSE OF THE LEAK IS UNKNOWN. THERE WAS NO REPORT OF DEATH OR INJURY AND NO ONE REQUIRED MEDICAL ATTENTION. THERE WAS NO REPORT OF EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMUNO-PREP REAGENT SYSTEM PRODUCTS, RED-CELL LYSING PRODUCTS GGK BECKMAN COULTER, INC. IMMUNO-PREP REAGENT 1099062K

    Patients

    Seq Age Sex Outcome Treatment
    1