BEUDAMED
    FDA Adverse Event Other Summary report: N

    HUMAPEN ERGO 3 ML

    MDR report key: 355201 · Received October 4, 2001

    Report

    Report Number
    1819470-2001-00048
    Event Type
    Other
    Date Received
    October 4, 2001
    Date of Event
    August 8, 2001
    Report Date
    September 14, 2001
    Manufacturer
    ELI LILLY AND COMPANY
    Product Code
    KZE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS DEVICE CASE, THE FIRST OF TWO CASES REPORTED BY A DIABETES NURSE, CONCERNS A PT WHO EXPERIENCED DIABETIC KETOACIDOSIS (DKA). THE PT WAS USING A PEN INJECTION DEVICE (HUMAPEN ERGO) TO DELIVER 30% SOLUBLE INSULIN/70% ISOPHANE INSULIN (HUMULIN M3) FOR THE TREATMENT OF DIABETES MELLITUS. THE PT'S MEDICAL HISTORY INCLUDED BEING DIAGNOSED WITH DIABETES MELLITUS IN 1951. THE PT WAS NOT TAKING ANY CONCOMITTANT MEDICATION. THE PT COMMENCED USING THE PEN INJECTION DEVICE TO DELIVER 30% SOLUBLE INSULIN/70% ISOPHANE INSULIN (28UNITS/14UNITS) IN 2000. IN 2001 THE PT EXPERIENCED DKA AND WAS HOSPITALIZED. THE REPORTER STATED THE PT WAS WINDING THE DOSE KNOB OF THE PEN BACKWARDS, DESPITE REPEATED EDUCATION ON THE CORRECT USE OF THE PEN. THE REPORTER FELT THIS IS A PROBLEM WITH THE WAY THE PEN HAS BEEN DESIGNED BECAUSE THE PTS DO NOT ALWAYS FOLLOW INSTRUCTIONS. THE RESULTS OF LABORATORY INVESTIGATIONS PERFORMED IN -JUL/2001 WERE AS FOLLOWS: GLYCATED HAEMOGLOBIN (HBA1C) 9%; UREA 5.1. ACTION WITH 30% SOLUBLE INSULIN/70% ISOPHANE INSULIN IS UNKNOWN. THE PT HAD FULLY RECOVERED IN SEP/2001. THE REPORTER DID NOT CONSIDER THE EVENT TO BE RELATED TO 30% SOLUBLE INSULIN/70% ISOPHANE INSULIN. THE REPORTER CONSIDERED THE DKA TO POSSIBLY BE RELATED TO THE PEN INJECTION DEVICE DESIGN AND USER ERROR. THE PEN WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45080 HUMAPEN ERGO 3 ML PEN INJECTOR KZE ELI LILLY AND COMPANY MS8335 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization