BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMAPEN ERGO, BURG-OPAQ/CLEAR CARTRIDGE HOLDER

    MDR report key: 698306 · Received April 7, 2006

    Report

    Report Number
    1819470-2006-00007
    Event Type
    Malfunction
    Date Received
    April 7, 2006
    Report Date
    March 14, 2006
    Manufacturer
    ELI LILLY AND CO.
    Product Code
    KZE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    THIS DEVICE CASE, WHICH DOES NOT INVOLVE AN ADVERSE EVENT, REPORTED BY A PHARMACIST, WHO CONTACTED THE COMPANY WITH A PRODUCT COMPLAINT CONCERNS A MALE PATIENT. THE PATIET WAS TAKING HUMULIN NPH (HUMINSULIN BASAL) VIA A HUMAPEN NPH ERGO (BURGUNDY/OPAQUE WITH A CLEAR CARTRIDGE HOLDER (CCH) ATTACHED FOR THE TREAMENT OF AN UNKNOWN INDICATION BEGINNING ON AN UNKNOWN DAY. ON AN UNKNOWN DAY, THE HUMAPEN ERGO, BURGUNDY/OPAQUE, CLEAR CARTRIDGE HOLDER (CCH) ATTACHED ESD REPORTED TO HAVE THE INJECTION SCREW NOT MOVING CORRECTLY. THE OPERATOR OF THE DEVICE WAS THE PATIENT. IT IS UNNKOWN IF THE OPERATOR OF THE DEVICE WAS TRAINED. THE PATIENT HAS USED THIS DEVICE MODEL FOR AN UNKNOWN TIME PERIOD. THE DEVICE WAS RETURNED TO THE COMPANY. IT IS UNKNOWN IF THE HUMAPEN ERGO BURGUNDY/OPAQUE, CCH ATTACHED IS CONTINUING. LOT NUMBER IS 14459.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMAPEN ERGO, BURG-OPAQ/CLEAR CARTRIDGE HOLDER PEN INJECTOR FOR TREATMENT PURPOSES KZE ELI LILLY AND CO. MS8343 A1459

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR