BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMAPEN ERGO 3 ML

    MDR report key: 425878 · Received November 1, 2002

    Report

    Report Number
    1819470-2002-00039
    Event Type
    Injury
    Date Received
    November 1, 2002
    Report Date
    October 8, 2002
    Manufacturer
    ELI LILLY AND CO.
    Product Code
    KZE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    THE PATIENT'S MEDICAL HISTORY INCLUDED: DIABETES ABOUT 20 YEARS. CONCOMITANT MEDICATIONS WERE PROVIDED AS FOLLOWS: HUMAN INSULIN ISOPHANE SUSPENSION (HUMULIN N ) FOR DIABETES. THE PATIENT TOOK HUMAN INSULIN LISPRO (HUMALOG), UNKNOWN DOSAGE, FOR THE TREATMENT OF DIABETES VIA HUMAPENS BEGINNING ON AN UNKNOWN DATE. ON AN UNKNOWN DATE AFTER BEGINNING HUMAN ISULIN WHILST HOLIDAYING THEY REALISED THEIR BLOOD GLUCOSE LEVELS WERE VERY HIGH AROUND 20 - 25 (UNITS UNKNOWN). THE PATIENT NOTED THAT WHEN THEY DIALED UP THEIR INSULIN, THE PLUNGER JAMMED AND NO INSULIN WAS COMING OUT AND BELIEVES THEY RECEIVED NO INSULIN FOR 3 DAYS. THE PATIENT WENT TO HOSPITAL AND WAS ADMITTED. THEY WERE PUT ON A DRIP AND MONITORED FOR 6 HOURS, BEFORE BEING RELEASED. PATIENT STATES THAT THE HUMAN INSULIN COULD NOT BE SWAPPED TO THEIR OTHER PEN AND CONTINUED THEIR INSULIN THERPY BY SYRINGE FOR THE REMAINDER OF THEIR HOLIDAY. THE PATIENT FULLY RECOVERED. THE PATIENT WENT TO SEE THEIR DIABETIC NURSE AND WAS GIVEN TWO NEW PENS. IT WAS UNKNOWN WHERE THE FAULTY PENS WERE, THEY MAY HAVE GIVEN THEM TO A NURSE. CONSUMER CASE SO NO RELATIONSHIP COULD BE DETERMINED. THIS REPORT IS CROSS REFERENCED WITH CID 153450.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMAPEN ERGO 3 ML PEN INJECTOR KZE ELI LILLY AND CO. MS8335 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Hospitalization THERAPY DATES: NI.| BRAND: HUMAPEN ERGO 3 ML TYPE: PEN INJECTOR.