BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOFINE 8MM (30G)

    MDR report key: 391341 · Received May 1, 2002

    Report

    Report Number
    9681821-2002-00022
    Event Type
    Injury
    Date Received
    May 1, 2002
    Report Date
    April 6, 2002
    Manufacturer
    NOVO NORDISK A/S, MEDICAL SYSTEMS
    Product Code
    FMI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    HYPERGLYCAEMIA [HYPERGLYCAEMIA NOS]. CASE DESCRIPTION: A PHYSICIAN REPORTED THAT A PATIENT WAS HOSPITALIZED DUE TO HYPERGLYCAEMIA, WHILE USING ACTRAPID PENFILL WITH A NOVOPEN 3 AND NOVOFINE 30G NEEDLES. IN 2002, THE PATIENT'S DIABETIC TREATMENT WAS CHANGED TO ACTRAPID VIAL AND PATIENT'S BLOOD GLUCOSE LEVELS NORMALIZED. COMMENT: THIS CASE IS LINKED TO CASE 214094, INITIALLY RECEIVED ON 02/2002. ON 04/2002 IT WAS REPORTED THAT NOVOFINE G30 AND NOVOPEN 3 ALSO ARE CONSIDERED AS SUSPECTED PRODUCTS. INFORMATION ON NOVOPEN 3 HAS BNEEN INCLUDED IN CASE 214094.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVOFINE 8MM (30G) NEEDLE FMI NOVO NORDISK A/S, MEDICAL SYSTEMS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Hospitalization