BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMAPEN EROG, TEAL/CLEAR

    MDR report key: 479521 · Received August 18, 2003

    Report

    Report Number
    1819470-2003-00025
    Event Type
    Malfunction
    Date Received
    August 18, 2003
    Report Date
    June 14, 2002
    Manufacturer
    ELI LILLY AND CO.
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    THIS DEVICE CASE, WHICH DOES NOT INVOLVE AN ADVERSE EVENT, REPORTED BY A CONSUMER, WHO CONTACTED THE CO WITH A PRODUCT COMPLAINT, CONCERNS A PT OF UNK AGE AND GENDER. THE PT'S MEDICAL HISTORY INCLUDED DIABETES MELLITUS. NO CONCOMITANT MEDICATION WAS PROVIDED. THE PT WAS TAKING HUMAN INSULIN LISPRO UNK FORMULATION VIA A PEN INJECTION DEVICE (HUMAPEN ERGO, MS8929, LOT401101, CCH ATTACHED) 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 REPORTED TO BE DEFECTIVE. THE DEVICE WAS RETURNED TO THE CO FOR ANALYSIS. REFER TO THE RESULTS/CONCLUSION SECTION. NO ADDITIONAL INFO IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMAPEN EROG, TEAL/CLEAR PEN INJECTOR FMF ELI LILLY AND CO. MS8929 40101

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO