BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMAPEN ERGO, UNK PEN BODY TYPE/UNK CH TYPE

    MDR report key: 1150556 · Received September 4, 2008

    Report

    Report Number
    1819470-2008-00045
    Event Type
    Injury
    Date Received
    September 4, 2008
    Report Date
    August 11, 2008
    Manufacturer
    ELI LILLY AND CO.
    Product Code
    FMF
    PMA / PMN Number
    K982842
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IF DEVICE IS RETURNED, EVAL WILL BE PERFORMED TO DETERMINE IF A MALFUNCTION HAS OCCURRED. NOTE: THIS IS AN INITIAL REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE FINAL EVAL IS COMPLETED.

    Description of Event or Problem · 1

    THIS CASE REPORTED BY A CONSUMER, WHO CONTACTED THE COMPANY FOR PRODUCT INFO, CONCERNED A FEMALE PT OF UNK AGE AND ORIGIN. MEDICAL HISTORY INCLUDED BEING DIABETIC FOR 50 YEARS (1960) AND HISTORICAL USE OF ANIMAL INSULIN 25 YEARS AGO (1983). CONCOMITANT MEDICAL INCLUDED INSULIN GLARGINE. THE PT RECEIVED INSULIN LISPRO (HUMALOG) VIA CARTRIDGE PER A HUMAPEN (HP) ERGO: UNK BODY TYPE, DOSING REGIMEN UNSPECIFIED, FOR THE TREATMENT OF DIABETES, BEGINNING ON AN UNSPECIFIED DATE. THE PT EXPERIENCED HER BLOOD SUGARS BECAME IRREGULAR AND FAINTED (DATE UNSPECIFIED) TO WHERE THE PARAMEDICS WERE CALLED AND WAS PUT ON INTRAVENOUS (IV) GLUCOSE. THE PT ALSO REPORTED THAT SHE WENT HYPOGLYCEMIC MOSTLY WHEN REACHING THE END OF THE CARTRIDGES. IT WAS UNK IF SHE RECOVERED FROM ANY OF THE EVENTS. THE MEDICATION ACTION TAKEN WITH HUMALOG WAS NOT PROVIDED. THIS HP ERGO REPORT INCLUDED A PRODUCT COMPLAINT, SUSPECT DEVICE (ATTEMPTED TO OBTAIN LOT NUMBER; INFO UNK). IT WAS UNK IF THE PT WAS A TRAINED USER OF THE DEVICE. GENERAL DEVICE AND PROBLEM DEVICE DURATION OF US WAS NOT PROVIDED. THE PEN WITH THE PROBLEM WAS USED AND ITS RETURN STATUS WAS NOT PROVIDED. ADDITIONAL INFO WILL BE REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMAPEN ERGO, UNK PEN BODY TYPE/UNK CH TYPE PEN INJECTOR FOR TREATMENT PURPOSES FMF ELI LILLY AND CO. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention