BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMAPEN ERGO, BURG/CLEAR

    MDR report key: 498635 · Received November 21, 2003

    Report

    Report Number
    1819470-2003-00040
    Event Type
    Malfunction
    Date Received
    November 21, 2003
    Report Date
    October 23, 2003
    Manufacturer
    ELI LILLY AND CO.
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS TAKING AN UNSPECIFIED MEDICATION VIA A HUMAPEN ERGO BURGUNDY/CLEAR (LOT# A1521) DEVICE. THE TABS AT THE BOTTOM OF THE CARTRIDGE HOLDER WERE BROKEN. THE CARTRIDGE HOLDER KEPT MOVING BECAUSE OF THIS. THE CALL RESPONSE CENTRE ASSOCIATE INFORMED THAT THE PATIENT TO PICK UP A NEW DEVICE AT THE DRUGSTORE. THE PATIENT AGREED TO RETURN THE PEN THROUGH THE MAIL. THE PATIENT WAS NOT IMPACTED AS A RESULT OF THIS PROBLEM. THE PATIENT OPERATED THE DEVICE AND WAS NOT A TRAINED USER. THE DEVICE AGE AND DURATION OF USE WAS TWO YEARS. THE PATIENT USED BD ULTRA-FINE III MINI (31 GAUGE, 5 MM) NEEDLE TIPS AND STORED THE DEVICE AT ROOM TEMPERATURE. THE RETURN OF THE DEVICE IS ANTICIPATED. THE CONTENTS OF THE COMPLAINT NARRATIVE SUGGEST THAT THIS DEVICE MAY HAVE HAD BOTH ENGAGEMENT TABS BROKEN. HOWEVER, THIS CANNOT BE CONFIRMED WITHOUT THE DEVICE. IN THE EVENT THAT THE DEVICE IS RETURNED, IT WILL BE EVALUATED TO DETERMINE IF A REPORTABLE MALFUNCTION/NEAR INCIDENT HAS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMAPEN ERGO, BURG/CLEAR PEN INJECTOR FMF ELI LILLY AND CO. MS8930 A1521

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO