BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMAPEN ERGRO, TEAL/CLEAR

    MDR report key: 718091 · Received July 26, 2005

    Report

    Report Number
    1819470-2005-00011
    Event Type
    Malfunction
    Date Received
    July 26, 2005
    Report Date
    June 14, 2005
    Manufacturer
    ELI LILLY AND CO.
    Product Code
    KZE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE PT WAS TAKING UNSPECIFIED INSULIN VIA A PEN INJECTION DEVICE [HUMAPEN ERGO TEAL/CLEAR CARTRIDGE HOLDER (CCH), MS8929, LOT UNK) FOR DIABETES MELLITUS. THE PERSON OPERATING THE DEVICE WAS THE PT. IT IS UNK IF THE OPERATOR OF THE DEVICE WAS TRAINED. THE PEN WAS FOUR YEARS OLD AND WAS REPORTED TO HAVE BROKEN ENGAGEMENT TABS ON THE CCH. THE PT SEEMED TO BE VERY DERANGED WHEN HE TALKED TO AN EMPLOYEE AT THE SERVICE CENTER. HE WANTED TO RETURN HIS DEFECTIVE DEVICE TO QUALITY CONTROL, BUT PRIOR TO BEING ABLE TO DO SO, HE WAS HOSPITALIZED. DUE TO PROBLEMS WITH HIS BACK, WHERE THEY TOOK AWAY THE DEFECTIVE PEN AND THREW IT AWAY. THE HOSPITALIZATION WAS NOT DUE TO HIS DIABETES AND HAD NOTHING TO DO WITH THE INSULIN OR THE DEVICE. THE DEVICE WAS NOT RETURNED TO THE CO.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *