BEUDAMED
    FDA Adverse Event Other Summary report: N

    HUMAPEN ERGO 3 ML

    MDR report key: 345230 · Received August 2, 2001

    Report

    Report Number
    1819470-2001-00038
    Event Type
    Other
    Date Received
    August 2, 2001
    Date of Event
    June 29, 2001
    Report Date
    July 4, 2001
    Manufacturer
    ELI LILLY AND CO.
    Product Code
    KZE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS DEVICE CASE, REPORTED BY A DIABETES SPECIALIST NURSE, CONCERNS A PT WHO EXPERIENCED DIABETIC KETOACIDOSIS (DKA). THE PT WAS USING A PEN INJECTION DEVICE (HUMAPEN ERGO) TO DELIVER 20% SOLUBLE INSULIN/80% ISOPHANE INSULIN (HUMULIN M2). THE DEVICE HAD A CLEAR CARTRIDGE HOLDER THAT WAS ATTACHED TO A TEAL/OPAQUE PEN BODY (MODEL MS8335, LOT A1501). THE PT WAS NOT TAKING CONCOMITTANT MEDICATION. THE PT EXPERIENCED DKA IN 2001 AND WAS HOSPITALIZED WHILE USING A PEN INJECTION DEVICE TO DELIVER 20% SOLUBLE INSULIN/80% ISOPHANE INSULIN. THE PT HAD SWITCHED FROM USING INSULIN VIALS TO HAD SWITCHED FROM USING INSULIN VIALS TO USING THE PEN INJECTION DEVICE A COUPLE OF WEEKS PRIOR TO THE REPORT. THE REPORTER DID NOT KNOW IF THE PEN HAD A MALFUNCTION OR THERE WAS A USER ERROR. INITIAL EXAMINATION OF THE RETURNED DEVICE REVEALED THERE WERE NO APPARENT DEFECTS WITH THE PEN. A PART USED 20% SOLUBLE ISULIN/80% ISOPHANE INSULIN CARTRIDGE WAS IN THE PEN. THE NEEDLE WAS REMOVED BEFORE THE PEN WAS RETURNED. ACTION WITH 20% SOLUBLE INSULIN/80% ISOPHANE INSULIN IS UNKNOWN. THE PT IS RECOVERING. THE REPORTER DID NOT KNOWN IF THE EVENT WAS RELATED TO THE PEN INJECTION DEVICE. THE REPORTER DOES NOT CONSIDER THE EVENT TO BE RELATED TO 20% SOLUBLE INSULIN/80% ISOPHANE INSULIN. FURTHER INFO HAS BEEN REQUESTED. THE PEN IS TO BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34948 HUMAPEN ERGO 3 ML PEN INJECTOR KZE ELI LILLY AND CO. MS8335 A1501

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization