BEUDAMED
    FDA Adverse Event Other Summary report: N

    HUMAPEN ERGO 3 ML

    MDR report key: 384386 · Received March 21, 2002

    Report

    Report Number
    1819470-2002-00007
    Event Type
    Other
    Date Received
    March 21, 2002
    Date of Event
    December 10, 2001
    Report Date
    February 27, 2002
    Manufacturer
    ELI LILLY AND COMPANY
    Product Code
    KZE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS CASE, REPORTED BY A HEALTH CARE PROFESSIONAL TO A REGULATORY AGENCY, CONCERNS A PT WHO EXPERIENCED RAISED BLOOD SUGARS AND WAS ADMITTED TO HOSPITAL. THE PT WAS USING A PEN INJECTION DEVICE (HUMAPEN ERGO-UNKNOWN CARTRIDGE HOLDER) TO DELIVER HUMAN INSULIN (UNKNOWN FORMULATION) FOR THE TREATMENT OF DIABETES. NO MEDICAL HISTORY OR CONCOMITANT MEDICATION WAS PROVIDED. IN 2001, THE PT EXPERIENCED RAISED BLOOD SUGARS AND WAS ADMITTED TO HOSPITAL WHILE PT WAS USING A PEN INJECTION DEVICE TO DELIVER HUMAN INSULIN. WHEN THE PT WAS SEEN BY A DIABETES NURSE, THE NURSE FOUND THE PEN INJECTION DEVICE TO BE FAULTY AND NOT DELIVERING INSULIN. THE PT DISCONTINUED USING THE COMPLAINT DEVICE. ACTION WITH INSULIN IS UNKNOWN. PT OUTCOME WAS NOT PROVIDED. THE REPORTER CONSIDERS THE EVENT TO BE RELATED TO THE PEN INJECTION DEVICE. THE REPORTER DID NOT PROVIDE A CAUSALITY ASSESSMENT RELATING TO THE INSULIN. FURTHER INFO HAS BEEN REQUESTED. THE COMPLAINT DEVICE HAS BEEN REQUESTED FOR EXAM (UNKNOWN IF COMPLAINT DEVICE IS AVAILABLE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMAPEN ERGO 3 ML PEN INJECTOR KZE ELI LILLY AND COMPANY MS8335 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization