BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMAPEN ERGO, TEAL/CLEAR

    MDR report key: 707188 · Received August 17, 2005

    Report

    Report Number
    1819470-2005-00012
    Event Type
    Malfunction
    Date Received
    August 17, 2005
    Report Date
    July 4, 2005
    Manufacturer
    ELI LILLY AND CO.
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS TAKING AN UNSPECIFIED INSULIN UNKNOWN FORMULATION VIA A PEN INJECTION DEVICE (HUMAPEN ERGO, MS8929, LOT NUMBER IS UNKNOWN, CLEAR CARTRIDGE HOLDER (CCH) ATTACHED) FOR DIABETES MELLITUS. THE PERSON OPERATING THE DEVICE WAS THE PATIENT. IT IS UNKNOWN IF THE OPERATOR OF THE DEVICE WAS TRAINED. THE PEN WAS REPORTED TO HAVE BROKEN TABS ON CCH. THE DEVICE WAS NOT YET RETURNED TO THE COMPANY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMAPEN ERGO, TEAL/CLEAR PEN INJECTOR FMF ELI LILLY AND CO. MS8929 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 *