BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMAPEN ERGO, TEAL/CLEAR

    MDR report key: 495594 · Received November 17, 2003

    Report

    Report Number
    1819470-2003-00039
    Event Type
    Injury
    Date Received
    November 17, 2003
    Date of Event
    August 16, 2003
    Report Date
    October 20, 2003
    Manufacturer
    ELI LILLY AND CO
    Product Code
    FMF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT RECEIVED HUMAN ISOPHANE INSULIN (HUMULIN N, LOT#FF2BF2B), DOSE UNKNOWN, VIA A HUMAPEN ERGO TEAL CLEAR CARTRIDGE (MS8929, LOT#40200), FOR TREATMENT OF DIABETES, BEGINNING ON AN UNKNOWN DATE. IN 2003, THE PT WAS ADMITTED TO THE HOSP WITH KETOACIDOSIS. DISCHARGED ONE WEEK LATER USE OF THE PEN WAS DISCONTINUED. PHYSICIAN ASSUMED THE PEN WAS NOT PRIMED AS SUGGESTED AND THE PT DID NOT CHECK THE CONDITION OF THE NEEDLE PRIOR TO USE. THE PHYSICIAN ALSO CONFIRMED THE MALFUNCTION. THE OPERATOR OF THE DEVICE WAS THE PT. THE USER WAS TRAINED BY THE PHYSICIAN. THE DEVICE WAS RETURNED TO THE AFFILIATE CO FOR ANALYSIS. NEITHER THE ATTORNEY NOR THE PT WOULD PROVIDE FURTHER INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMAPEN ERGO, TEAL/CLEAR PEN INJECTOR FMF ELI LILLY AND CO MS8929 40200

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Hospitalization