BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOFINE

    MDR report key: 8735420 · Received June 25, 2019

    Report

    Report Number
    MW5087625
    Event Type
    Injury
    Date Received
    June 25, 2019
    Date of Event
    June 22, 2019
    Report Date
    June 22, 2019
    Manufacturer
    NOVO NORDISK INC.
    Product Code
    FMI
    UDI-DI
    00653020266514
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT ON 3RD ADMISSION FOR DKA AFTER REVIEWING USE OF THE NOVOFINE AUTOSHIELD PEN, I AM EXTENDING CONCERN THE NEEDLE MAY BE MALFUNCTION. DIRECT OBSERVATION OF PEN USE BY MEDICAL STAFF. PT APPLIED NEEDLE APPROPRIATELY TO INSULIN PEN. WATCHED AND OBSERVED PT WAS ABLE TO APPROPRIATELY APPLY PRESSURE TO OPEN AND ABLE TO HEAR NEEDLE SHIELD CLICK, RED "USED" FLAGS ON SIDE SHOW. PT APPROPRIATELY HELD SYRINGE IN PLACE FOR 5 SECS BEFORE REMOVING PEN FROM HER SKIN. LARGE AROUND OF INSULIN TRICKLES DOWN PT SKIN, NO PUNCTURE WOUND VISIBLE. PLEASE REVIEW LOT NUMBER AND SEE IF THIS IS A BAD BATCH. PT IS NOW ON 3RD ADMISSION FOR DKA SINCE USING THESE NEEDLES. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526692 NOVOFINE NEEDLE HYPODERMIC, SINGLE LUMEN FMI NOVO NORDISK INC. 30G X 8 MM 19A12U 00653020266514

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization