BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMAPEN ERGO, BURG/CLEAR

    MDR report key: 614460 · Received July 19, 2004

    Report

    Report Number
    1819470-2005-00017
    Event Type
    Malfunction
    Date Received
    July 19, 2004
    Report Date
    June 14, 2004
    Manufacturer
    ELI LILLY AND CO.
    Product Code
    KZE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    THE PT'S MEDICAL HISTORY INCLUDED DIABETES. CONCOMITANT MEDICATION WAS NOT REPORTED. THE PT WAS TAKING INSULIN LISPRO (HUMALOG, CARTRIDGE) VIA A HUMAPEN ERGO (MODEL MS8930, LOT A1508) WITH CLEAR CARTRIDGE HOLDER ATTXAHED, FOR TREATMENT OF DIABETES. PT BOUGHT THE INVOLVED PEN IN 2002, WHICH WAS A NEW DESIGN PEN. THE PT OPERATED THE DEVICE. THEY CAN SELET THE DOSE BUT THEY CANNOT INJECT IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMAPEN ERGO, BURG/CLEAR PEN INJECTOR KZE ELI LILLY AND CO. MS8930 40086

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO