BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEMIR FLEXPEN 100U/ML

    MDR report key: 1050128 · Received May 22, 2008

    Report

    Report Number
    MW5007005
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    May 1, 2008
    Report Date
    May 22, 2008
    Manufacturer
    NOVO NOR INC
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT REPORTS THAT THE FLEXPEN INFECTOR DOES NOT INJECT INSULIN WHEN PUSHED, STATES THAT THIS IS VERY COSTLY TO HER AND MEDICARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEVEMIR FLEXPEN 100U/ML NOVO NOR DISK A-F FMF NOVO NOR INC

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR