BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVOPEN JUNIOR

    MDR report key: 443005 · Received February 13, 2003

    Report

    Report Number
    MW1027538
    Event Type
    Malfunction
    Date Received
    February 13, 2003
    Date of Event
    February 13, 2003
    Report Date
    February 13, 2003
    Manufacturer
    NOVA NORDISK PHARMACEUTICALS, INC.
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    REPORTER CALLING REGARDING FALSE/MISLEADING ADVERTISING ON THE NOVAPEN JUNIOR. AN ADVERTISTMENT IN THE MARCH ISSUE OF "DIABETES FORCAST" INDICATES THAT THE NOVAPEN JUNIOR CAN DELIVER 1/2 UNITS OF INSULIN, A FLEXIBLE DELIVERY SYSTEM. THE AD DOES NOT SAY THAT IT CAN DELIVER 1/2 UNITS AFTER THE FIRST UNIT. THE PT AT TIMES REQUIRES 1/2 UNITS AND IS VERY SENSITIVE TO THE AMOUNT OF INSULIN RECEIVED. INITIALLY THE REPORTER'S PHARMACIST CALLED THE MFR AND WAS TOLD SYSTEM WOULD DELIVER 1/2 UNITS (ABOUT 1 WEEK AGO). REPORTER NOTED DISCREPANCY IN THE ADVERTISEMENT, CALLED MFR FOR CLARIFICTION AND WAS TOLD "YOU JUST WANTED TO HEAR WHAT YOU WANTED TO HEAR." REPORTER ASKED TO SPEAK TO A SUPERVISOR, THE CALL WAS DISCONNECTED ("HUNG UP") AND THE REPORTER WAS NOT ABLE TO GET THROUGH ON SUBSEQUENT CALLS. NO REPORT WAS TAKEN BY MFR. REPORTER CONCERNED ABOUT POTENTIAL RISK OF OVER ADMINISTRATION OF INSULIN, MISLEADING ADVERTISEMENT AND THE "HOSTILE MANIPULATION" BY MFR REP DURING PHONE CALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVOPEN JUNIOR INSULIN DELIVERY SYSTEM FMF NOVA NORDISK PHARMACEUTICALS, INC. * MV40130

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR