BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INNOVA WITH NOVOLOG PEN-FILL CARTRIDGE

    MDR report key: 458776 · Received May 8, 2003

    Report

    Report Number
    MW1028380
    Event Type
    Injury
    Date Received
    May 8, 2003
    Date of Event
    May 3, 2003
    Report Date
    May 8, 2003
    Manufacturer
    NOVO NORDISK PHARMACEUTICAL INDUSTRIES, INC.
    Product Code
    KZE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WV, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    DEVICE MALFUNCTION CAUSING HOSPITAL ADMISSION: PT USES INNOVA "PEN CARTRIDGE INJECTOR" FOR NOVALOG INSULIN; BEFORE MEALS AND ADJUSTING SLIDING SCALE DOSE WHEN NEEDED FOR HIGH GLUCOSE READINGS. CARTRIDGE HOLDS 300 UNITS OF INSULIN, BUT APPARENTLY IT STOPS GIVING ANY INJECTIONS WHEN REMAINING INSULIN VOLUME IS 50 UNITS; NO ALARM IS SOUNDED OR COMMUNICATED THAT DOSES ARE NOT ACTUALLY BEING GIVEN - PER PT AND PER DIABETES EDUCATION NURSE -. PT THEREFORE THOUGHT THEY WERE TREATING SELF APPROPRIATELY BUT BG'S KEPT GOING HIGHER AND HIGHER UNTIL THEY ACTUALLY DEVELOPED DKA AND REQUIRED ICU ADMISSION. INITIAL BG ON ADMIT WAS 575, HCO3 WAS 6, BASE DEFICIT WAS 24.6 MEQ. PT RESPONDED TO INSULIN AND FLUID RESUSCITATION IN THE HOSPITAL, AND WAS DISCHARGED AFTER 3.5 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INNOVA WITH NOVOLOG PEN-FILL CARTRIDGE INSULIN INJECTOR KZE NOVO NORDISK PHARMACEUTICAL INDUSTRIES, INC. UNK *

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Hospitalization| L| R