BEUDAMED
    FDA Adverse Event Other Summary report: N

    HUMAPEN ERGO 3 ML

    MDR report key: 381983 · Received March 7, 2002

    Report

    Report Number
    1819470-2002-00006
    Event Type
    Other
    Date Received
    March 7, 2002
    Date of Event
    September 19, 2001
    Report Date
    February 6, 2002
    Manufacturer
    ELI LILLY AND CO.
    Product Code
    KZE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS CASE, REPORTED BY A SOLICITOR, CONCERNS A PATIENT WHO EXPERIENCED DIABETIC KETOACIDOSIS AND WAS ADMITTED TO HOSPITAL. THE PATIENT WAS USING A PEN INJECTION DEVICE (HUMAPEN ERGO-UNKNOWN CARTRIDGE HOLDER) TO DELIVER HUMAN INSULIN (UNKNOWN FORMULATION) FOR THE TREATMENT OF INSULIN DEPENDENT DIABETES. NO MEDICAL HISTORY OR CONCOMITANT MEDICATION WAS PROVIDED. ON THE DAY OF THE EVENT, THE PATIENT EXPERIENCED VERY POORLY CONTROLLED DIABETES AND WAS ADMITTED TO HOSPITAL WHILE PATIENT WAS USING A PEN INJECTION DEVICE TO DELIVER HUMAN INSULIN. THE PATIENT WAS ADMITTED TO HOSPITAL ON TWO OCCASIONS AND DIAGNOSED WITH DIABETES KETOACIDOSIS. FOLLOWING THE SECOND ADMISSION TO HOSPITAL THE DIABETIC SUPPORT NURSE NOTED THAT THE BARREL WAS LOOSE ON THE PEN INJECTION DEVICE AND CONCLUDED THAT THE INCORRECT DOSE OF INSULIN WAS BEING GIVEN. THE PATIENT DISCONTINUED USING THE COMPLAINT DEVICE WHICH WAS REPLACED WITH ANOTHER MANUFACTURER'S DEVICE. ACTION WITH INSULIN IS UNKNOWN. PATIENT 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. THE COMPLAINT DEVICE HAS BEEN REQUESTED FOR EXAMINATION FROM THE REPORTER. NO FURTHER FOLLOW UP IS POSSIBLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Hospitalization