BEUDAMED
    FDA Adverse Event Other Summary report: N

    HUMAPEN ERGO 3 ML

    MDR report key: 351621 · Received September 7, 2001

    Report

    Report Number
    1819470-2001-00042
    Event Type
    Other
    Date Received
    September 7, 2001
    Date of Event
    August 10, 2001
    Report Date
    August 13, 2001
    Manufacturer
    ELI LILLY AND CO.
    Product Code
    KZE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS DEVICE CASE, REPORTED BY NURSE, WITH FURTHER INFO FROM A SECOND NURSE, CONCERNS A PT WHO EXPERIENCED HIGH BLOOD GLUCOSE LEVELS AND WAS HOSPITALIZED. THE PT WAS USING A PEN INJECTION DEVICE (HUMAPEN ERGO) TO DELIVER 20% SOLUBLE INSULIN/80% ISOPHANE INSULIN (HUMALOG M2) FOR THE TREATMENT OF TYPE II DIABETES MELLITUS. THE PT HAD STARTED USING THE PEN INJECTION DEVICE ONE WEEK PRIOR TO THE REPORT. THE PT PRESENTED AT THE CLINIC FEELING UNWELL ON THE DAY OF THE EVENT. ON EXAMINATION IT WAS FOUND THE PTS BLOOD GLUCOSE LEVEL WAS 39.9MMOL/L AND THE PT WAS ADMITTED TO HOSP BY THE CONSULTANT PHYSICIAN. THE PT WAS STILL IN HOSP THREE DAYS LATER. THE REPORTER STATED THAT WHEN THE PLUNGER OF THE PEN WAS DEPRESSED, THE ROD THAT PUSHES DOWN THE BUNG ON THE INSULIN CARTRIDGE WAS ONLY WORKING INTERMITTENTLY. THE PT HAS NOT YET RECOVERED. THE EVENTS ARE UNASSESSED BY A HEATLTH PROFESSIONAL. FURTHER INFO HAS BEEN REQUESTED. THE PEN IS TO BE RETURNED. UPDATE 08/21/2001: FURTHER INFO REC'D FROM A SECOND NURSE. PT INFO, THERAPY INFO AND DEVICE INFO. UPDATE 08/22/2001: PRELIMINARY COMMENTS RECEIVED FROM PHARMACEUTICAL DELIVERY SYSTEM (PDS) ON 08/21/2001. PRELIMINARY REPORT PREPARED.

    Description of Event or Problem · 1

    RESULTS AND CONCLUSIONS RECEIVED FROM PHARMACEUTICAL DELIVERY SYSTEMS (PDS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40819 HUMAPEN ERGO 3 ML PEN INJECTOR KZE ELI LILLY AND CO. MS8335 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization