BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOFINE 30

    MDR report key: 622699 · Received July 25, 2005

    Report

    Report Number
    9681821-2005-00030
    Event Type
    Injury
    Date Received
    July 25, 2005
    Date of Event
    June 27, 2005
    Report Date
    June 27, 2005
    Manufacturer
    NOVO NORDISK A/S - MEDICAL SYSTEMS
    Product Code
    FMI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT, RECEIVED FROM A CONSUMER, REPORTED AS "NEEDLE BROKEN OF IN ABDOMEN", CONCERNS A PT USING A NOVOFINE 30G NEEDLE. THE PT WAS DIAGNOSED WITH TYPE II DIABETES MELLITUS IN 06/1994. THE PT WAS IN A LOCAL HOSPITAL DUE TO THEIR DIABETES IN 2005. THE NEXT DAY THE PT INITIALTED INSULIN THERAPY WITH NOVOLIN 30R (DUAL-ACTING HUMAN INSULIN) USING A NOVOPEN 30G NEEDLE. A MONTH LATER, BEFORE INJECTION, THE CONSUMER DROPPED THE NOVOPEN 3 ON THE GROUND AND THE NOVOFINE 30G NEEDLE WAS BENT. THE PT MANAGED TO STRAIGHTEN THE NEEDLE AND USED IT FOR INJECTION. AFTER INJECTION, THE PT FOUND THAT THE NEEDLE WAS BROKEN OFF THEIR ABDOMINAL REGION (SUBCUTANEOUS). THE PT THEN WENT TO THE LOCAL HOSP AND X-RAY EXAMINATION COULD NOT LOCAL THE BROKEN NEEDLE. THE BROKEN NEEDLE IS STILL INSIDE THE PT'S BODY. REPORTEDLY, THE PT PERFORMED AIRSHOTS PRIOR TO INJECTION, BUT PT HAD BEEN USING THE NEEDLE IN QUESTION FOR THREE DAYS. HOWEVER, NO FUNCTION CHECK FOR THE DEVICE WAS DONE. THE PT IS STILL IN HOSP, AND THE OUTCOME OF THE VENT IS REPORTED AS UNKNOWN. THE PT DOES NOT TAKEN ANY OTHER CONCOMITANT MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVOFINE 30 NEEDLE FMI NOVO NORDISK A/S - MEDICAL SYSTEMS NA 04A09D

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R