BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVOLOG FLEXPEN

    MDR report key: 2098694 · Received May 16, 2011

    Report

    Report Number
    2098694
    Event Type
    Malfunction
    Date Received
    May 16, 2011
    Date of Event
    May 10, 2011
    Report Date
    May 16, 2011
    Manufacturer
    NOVO NORDISK, INC.
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US

    Narratives

    Description of Event or Problem · 1

    THE NURSE ROTATED THE INSULIN PEN TO THE DESIRED NUMBER OF UNITS AND A SECOND NURSE VERIFIED THE DOSAGE. WHEN THE NURSE PRESSED THE PLUNGER, A "POPPING" SOUND WAS HEARD AND IT WAS NOTED THE PEN DID NOT DECREASE. THE NURSE ATTEMPTED TO TEST THE PEN AGAIN USING ONE UNIT AND THE SAME THING OCCURED. THERE WAS NO PATIENT INJURY. THE PEN WAS RETURNED TO THE PHARMACY AND THE REMAINING PENS (APPROXIMATELY 40) WITH THE SAME LOT NUMBERS WERE PULLED FROM STOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVOLOG FLEXPEN INSULIN FLEXPEN/3ML PREFILLED INSULIN SYRINGE FMF NOVO NORDISK, INC. * AZFO147

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES