BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMAPEN ERGO, TEAL/CLEAR

    MDR report key: 443067 · Received February 6, 2003

    Report

    Report Number
    1819470-2003-00001
    Event Type
    Malfunction
    Date Received
    February 6, 2003
    Report Date
    January 13, 2003
    Manufacturer
    ELI LILLY AND CO
    Product Code
    KZE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    A PT WAS USING A PEN INJECTION DEVICE (HUMAPEN ERGO - CLEAR CARTRIDGE HOLDER) TO DELIVER INSULIN FOR THE TREATMENT OF DIABETES. NO MEDICAL HISTORY OR CONCOMITANT MEDICATION DETAILS WERE PROVIDED. THE PEN WILL BE RETURNED WITH THE COMPLAINT: THE HUMAPEN IS A COUPLE OF MONTHS OLD WITH CCH. THE REPORTER IDENTIFIED TWO BROKEN TABS. THE REPORTER STATED THEY OBSERVED TWO BROKEN TRIANGLES FROM THE BOTTOM OF THE CLEAR PLASTIC CARTRIDGE HOLDER. THE CARTRIDGE HOLDER WAS CONFIRMED TO HAVE A SCALE OF 20-260 AND HAD HUMAPEN PRINTED ON THE SIDE. THE REPORTER STATED THAT THE PEN "HAD NOT BEEN DROPPED AT ALL". NO ADVERSE DRUG EVENT WAS REPORTED WITH THE COMPLAINT. THE PEN IS DUE TO BE RETURNED FOR FURTHER ANALYSIS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO