BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMAPEN ERGO, TEAL/OPAQUE

    MDR report key: 512455 · Received January 9, 2004

    Report

    Report Number
    1819470-2004-00001
    Event Type
    Malfunction
    Date Received
    January 9, 2004
    Report Date
    December 15, 2003
    Manufacturer
    ELI LILLY AND CO.
    Product Code
    KZE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS TAKING AN UNSPECIFIED MEDICATION VIA A HUMAPEN ERGO TEAL/OPAQUE PEN BODY (LOT NUMBER A1449) FITTED WITH A CLEAR CARTRIDGE HOLDER FOR AN UNKNOWN INDICATION. THE PERSON OPERATING THE DEVICE WAS THE PATIENT. IT IS UNKNOWN IF THE OPERATOR OF THE DEVICE WAS TRAINED. THE DEVICE WAS REPORTED AS BROKEN. THE DEVICE WAS RETURNED TO THE CO. INITIAL ANALYSIS BY THE QUALITY ASSURANCE DEPARTMENT FOUND: TWO BROKEN ENGAGEMENT TABS. THE PRODUCT IS OUT OF SPECIFICATION FOR DOSE ACCURACY. TWO TAB BREAKAGE HAS BEEN SHOWN TO RESULT IN AN UNDERDOSE OF PRODUCT. THE DEVICE WAS RETURNED TO THE MFR FOR ADDITIONAL EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMAPEN ERGO, TEAL/OPAQUE PEN INJECTOR KZE ELI LILLY AND CO. MS8335 A1449

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO