BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOPEN 3

    MDR report key: 592709 · Received April 19, 2005

    Report

    Report Number
    9681821-2005-00012
    Event Type
    Injury
    Date Received
    April 19, 2005
    Date of Event
    December 30, 2004
    Report Date
    March 21, 2005
    Manufacturer
    NOVO NORDISK A/S - MEDICAL SYSTEMS
    Product Code
    FMF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT, WHO IS USING PROTAPHANE (LONG-ACTING HUMAN INSULIN), NOVORAPID (INSULIN ASPART), NOVORAPID FLEXPEN (INSULIN ASPART) AND NOVOPEN 3 (INSULIN DELIVERY DEVICE) DUE TO DIABETES MELLITUS, EXPERIENCED HYPOGLYCAEMIC COMA IN 2004 AND WAS HOSPITALIZED. THE OUTCOME OF THE EVENT WAS NOT REPORTED. THE PT HAD ANOTHER EVENT OF HYPOGLYCAEMIC COMA TWELVE DAYS EARLIER AND WAS HOSPITALIZED FOR THREE DAYS (CASO NO. 241479), BUT THE INSULIN DELIVERY DEVICE WAS NOT INVOLVED IN THAT EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVOPEN 3 INSULIN DELIVERY DEVICE FMF NOVO NORDISK A/S - MEDICAL SYSTEMS NA KSCE823

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization