BEUDAMED
    FDA Adverse Event Other Summary report: N

    HUMAPEN ERGO, BURG/CLEAR

    MDR report key: 495980 · Received November 7, 2003

    Report

    Report Number
    1819470-2003-00037
    Event Type
    Other
    Date Received
    November 7, 2003
    Report Date
    October 10, 2003
    Manufacturer
    ELI LILLY AND CO.
    Product Code
    KZE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    THE PT'S MEDICAL HISTORY WAS NOT PROVIDED. ANY CONCOMITANT MEDICATIONS WERE UNKNOWN. THE PT WAS TAKING AN UNKNOWN INSULIN VIA A BURGUNDY HUMAPEN ERGO WITH CLEAR CARTRIDGE HOLDER (LOT#UNKNOWN/MODEL#MS8930) FOR AN UNKNOWN INDICATION. THE PT REPORTED THE FOLLOWING COMPLAINT TO THE LILLY AFFILIATE: THE PEN WAS NOT WORKING PROPERLY AND NO INSULIN WAS DELIVERED. ON AN UNKNOWN DATE THE PT EXPERIENCED A SERIOUS ADVERSE EVENT OF BLOOD GLUCOSE LEVEL OF 600MG/DL. THE PT'S FAMILY MEMBER GAVE THEIR PEN TO PT. AFTER USING THE PEN THE PT'S GLUCOSE LEVEL RETURNED TO NORMAL. THE EVENT DID NOT CONTINUE AND THE PT RECOVERED. THE PT OPERATED THE DEVICE AND WAS A TRAINED USER. THE DURATION OF USE WAS UNKNOWN. THE DEVICE WAS DISCONTINUED. THE DEVICE WAS RETURNED TO THE COMPANY FOR ANALYSIS IN 2003, INVESTIGATION IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMAPEN ERGO, BURG/CLEAR PEN INJECTOR KZE ELI LILLY AND CO. MS8930 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other