BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOFINE 8MM (30G) AUTOCOVER

    MDR report key: 2265015 · Received September 21, 2011

    Report

    Report Number
    9681822-2011-00003
    Event Type
    Injury
    Date Received
    September 21, 2011
    Report Date
    September 15, 2011
    Manufacturer
    NOVO NORDISK A/S - MS HJOERRING
    Product Code
    FMI
    PMA / PMN Number
    K050106
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NOVOFINE AUTOCOVER PRESCRIBED AND USED INSTEAD OF NOVOFINE NEEDLES [WRONG DEVICE DISPENSED] (DIABETIC KETOACIDOSIS). CASE DESCRIPTION: THIS INCIDENT DOES NOT REPRESENT A SERIOUS PUBLIC HEALTH THREAT. CLASSIFICATION OF THE INCIDENT: ALL OTHER REPORTABLE INCIDENTS. THIS SPONTANEOUS CASE FOR THE (B)(6) WAS REPORTED BY A NURSE AS "NOVOFINE AUTOCOVER PRESCRIBED AND USED INSTEAD OF NOVOFINE NEEDLES" AND "DIABETIC KETOACIDOSIS" AND CONCERNS A MALE PT OF UNK AGE WHO USED NOVOFINE 8MM (30G) AUTOCOVER NEEDLES FOR DEVICE THERAPY DUE TO TYPE 1 DIABETES MELLITUS. PT'S HEIGHT: NOT REPORTED MEDICAL HISTORY INCLUDES TYPE 1 DIABETES MELLITUS. THE PT HAD BEEN PRESCRIBED NOVOFINE AUTOCOVER INSTEAD OF NOVOFINE NEEDLES AND WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS. OUTCOME OF THE EVENTS IS NOT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization