BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IGA REAGENT

    MDR report key: 2020845 · Received March 16, 2011

    Report

    Report Number
    2050012-2011-00744
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    February 14, 2011
    Report Date
    February 14, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    CZP
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAK WAS DUE TO LOOSE CAP. SERVICE WAS NOT DISPATCHED. THIS IS NOT A DEVICE ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT IGA REAGENT LEAKED WHILE UNLOADING SHIPPING BOXES. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IGA REAGENT IGA IMMUNOASSAY CZP BECKMAN COULTER INC. IGA REAGENT N/A

    Patients

    Seq Age Sex Outcome Treatment
    1