BEUDAMED
    FDA Adverse Event Other Summary report: N

    HUMAPEN ERGO 3 ML

    MDR report key: 354376 · Received October 1, 2001

    Report

    Report Number
    1819470-2001-00046
    Event Type
    Other
    Date Received
    October 1, 2001
    Date of Event
    August 30, 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
    UK
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS DEVICE CASE, THE SECOND OF TWO CASES REPORTED BY A DIABETES NURSE, CONCERNS A PT WHO EXPERIENCED DIABETIC KETOACIDOSIS (DKA) TWICE. THE PT WAS USING A PEN INJECTION DEVICE (HUMAPEN ERGO) TO DELIVER ISOPHANE INSULIN (HUMULIN I) FOR THE TREATMENT OF TYPE II DIABETES MELLITUS. THE PT WAS NOT TAKING ANY CONCOMITTANT MEDICATION. WHILE TAKING ISOPHANE INSULIN (14/12/14/24 UNITS) THE PT EXPERIENCED DKA ON TWO DIFFERENT OCCASIONS AND WAS HOSPITALIZED ON EVENT DATE. THE REPORTER STATED THE PT WAS WINDING THE DOSE KNOB ON 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. ACTION WITH ISOPHANE INSULIN IS UNKNOWN. THE PT HAS FULLY RECOVERED. THE REPORTER DID NOT CONSIDER THE EVENT TO BE RELATED TO ISOPHANE INSULIN. THE REPORTER CONSIDERED THE DKA TO POSSIBLY BE RELATED TO THE PEN INJECTION DEVICE DESIGN AND USER ERROR. THE PEN WILL BE RETURNED. UPDATE 21-SEP-2001: QUALITY ASSURANCE (QA) REPORT RECEIVED FROM QA. NO PEN RETURNED. UPDATE 24-SEP-2001: PRELIMINARY REPORT RECEIVED FROM PRODUCT DELIVERY SYSTEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44324 HUMAPEN ERGO 3 ML PEN INJECTOR KZE ELI LILLY AND COMPANY MS8335 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization