BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEX - PEN

    MDR report key: 3202299 · Received June 28, 2013

    Report

    Report Number
    MW5030715
    Event Type
    Injury
    Date Received
    June 28, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 28, 2013
    Manufacturer
    NOVO NORDISK
    Product Code
    FMI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER STATES THAT, HE IS A DIABETIC PT WHO HAS BEEN USING THE FLEX-PEN FOR A WHILE NOW AND IT HAS BEEN HAVING THE SAME ISSUES. HE REPORTS THAT ALMOST EVERY PEN HE USES IS DEFECTIVE. IT FREQUENTLY JAMS AND WHEN IT DOES, IT IS VIRTUALLY IMPOSSIBLE TO FIX. SOME TIMES HE HAS TO USE FORCE TO INJECT THE INSULIN AND AFTER HE DOES THAT, ON RETRIEVING THE NEEDLE FROM HIS TISSUE INSULIN SPRAYS OUT ONTO HIS BODY. THIS CAUSES WASTE, WRONG DOSAGE AND SOMETIMES HYPO/HYPERGLYCEMIC EPISODES. THIS IS VERY COMMON WHEN HE HAS TO ADMINISTER ABOUT 40 UNITS. NOW HE IS FORCED TO ADMINISTER 10 UNITS AT A TIME WHICH IS A WASTE OF TIME AND HE IS NOT SURE IF THE AMOUNT DELIVERED IS ACCURATE. HE HAS COMPLAINED TO THE PHARMACY WHICH DIRECTED HIM TO CALL THE MFR. THE MANUFACTURE ASKED HIM TO SHIP THE DEFECTIVE PENS FOR REPLACEMENT AND NOW AT (B)(6) OF AGE, HE HAS TO VISIT THE POST OFFICE FREQUENTLY TO RETURN THESE PENS BECAUSE 9 OUT OF 10 IS DEFECTIVE. REPORTER PLEADS WITH THE FDA FOR THESE FLEX-PENS TO BE RECALLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295970 FLEX - PEN NONE FMI NOVO NORDISK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR