BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOFINE 8MM (30G)

    MDR report key: 3911632 · Received June 27, 2014

    Report

    Report Number
    9681821-2014-00029
    Event Type
    Injury
    Date Received
    June 27, 2014
    Report Date
    June 3, 2014
    Manufacturer
    NOVO NORDISK A/S, MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K861686
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    LEAKAGE AT THE INJECTION SITE [INJECTION SITE EXTRAVASATION] BLOOD GLUCOSE SPIKES [BLOOD GLUCOSE INCREASED]. CASE DESCRIPTION: DOES THE INCIDENT REPRESENT A SERIOUS PUBLIC HEALTH TREAT?: NO. THIS SERIOUS SPONTANEOUS CASE FROM THE UNITED STATES WAS REPORTED BY A NURSE VIA A SUPPLY MANAGER FOR A HOSPITAL AS "LEAKAGE AT THE INJECTION SITE" AND "BLOOD GLUCOSE SPIKES" ON AN UNSPECIFIED DATE, AND CONCERNS A CHILD (AGE AND GENDER NOT REPORTED) WHO WAS TREATED WITH NOVOFINE 8MM (30 G) NEEDLE) FROM AN UNKNOWN START DATE FOR DEVICE THERAPY. PATIENT'S HEIGHT, WEIGHT AND BMI (BODY MASS INDEX) WAS NOT PROVIDED. MEDICAL HISTORY WAS NOT PROVIDED. IT WAS REPORTED THAT NURSE NOTICED LEAKAGE AT THE INJECTION SITE WITH THE USE OF NOVOFINE 8 MM 30G 8MM NEEDLES. THE CHILD WAS CURRENTLY ADMITTED IN THE HOSPITAL AS EXPERIENCED BLOOD GLUCOSE SPIKES WHEN THE INJECTION SITE LEAKAGE OCCURRED. ACTION TAKEN TO NOVOFINE 30G WAS NOT REPORTED. THE OVERALL OUTCOME WAS NOT REPORTED. CONTACT INFORMATION FOR THE NURSE WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376471 NOVOFINE 8MM (30G) NEEDLE FMF NOVO NORDISK A/S, MEDICAL SYSTEMS NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization