BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIQUI-SERA

    MDR report key: 11399 · Received February 9, 1994

    Report

    Report Number
    MW1000691
    Event Type
    Malfunction
    Date Received
    February 9, 1994
    Report Date
    February 8, 1994
    Manufacturer
    BIO DIAGNOSTICS, INTL.
    Product Code
    GIF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PLASTIC CONTAINER THAT THE PRODUCT IS PACKAGED IN, LEACHES INTO THE REAGENT RENDERING IT UNSTABLE. THE MFR IS AWARE OF THE PROBLEM AND IS PLANNING TO PACKAGE THE PRODUCT IN A GLASS CONTAINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIQUI-SERA GIF BIO DIAGNOSTICS, INTL. ALL

    Patients

    Seq Age Sex Outcome Treatment
    1 *