BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVOFINE 30

    MDR report key: 300945 · Received October 16, 2000

    Report

    Report Number
    MW1020181
    Event Type
    Malfunction
    Date Received
    October 16, 2000
    Date of Event
    October 16, 2000
    Report Date
    October 16, 2000
    Manufacturer
    NOVO NORDISK PHARMACEUTICALS, INC.
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    COULD NOT GET 70/30 INSULIN TO FLOW THROUGH NOVOFINE NEEDLE LOT NUMBER 99JO 7C EXPIRES 8/2004. ITEM MADE BY NOVO NORDISK. ALSO MIGHT HAVE COMPROMISED THE LONGIVITY OF NOVOPEN 1.5 BY TRYING OT GET THE DOSAGE FORM INTO PT. PT HAS THE DEFECTIVE DEVICE IN POSSESSION. PT WANTS INFO ON HOW TO HELP PREVENT SAME PROBLEM OCCURRING TO OTHERS. RPTR IS CONCERNED ABOUT THE INTEGRITY OF NOVOPEN 1.5 DEVICE SINCE RPTR PUT PRESSURE ON IT IN AN ATTEMPT TO GET MEDICATION THROUGH IT INTO RPTR. HAD NO PROBLEM WHEN RPTR CHANGED NEEDLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVOFINE 30 NEEDLE TO ATTACH TO A NOVOPEN 1.5 FMI NOVO NORDISK PHARMACEUTICALS, INC. NA 99J07C

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other SUBCUTANEOUS| 1. 18 UNITS EACH AM ARTERIOR/POSTERIOR| 2. 15 UNITS EACH PM ANTERIOR/POSTERIOR| SUBCUTANEOUS