BEUDAMED
    FDA Adverse Event Other Summary report: N

    HUMAPEN ERGO, TEAL/OPAQUE

    MDR report key: 405307 · Received July 11, 2002

    Report

    Report Number
    1819470-2002-00021
    Event Type
    Other
    Date Received
    July 11, 2002
    Date of Event
    January 1, 2002
    Report Date
    June 19, 2002
    Manufacturer
    ELI LILLY AND CO.
    Product Code
    KZE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS DEVICE CASE, REPORTED BY A NON HEALTH CARE PROFESSIONAL WHO CONTACTED THE CO WITH A PRODUCT COMPLAINT, CONCERNS A PT. NO MEDICAL HISTORY WAS PROVIDED. THE PT WAS NOT RECEIVING ANY OTHER CONCOMITANT MEDICATION. THE PT HAD BEEN RECEIVING 25% INSULIN LISPRO SOLUTION/ 75% INSULIN LISPRO PROTAMINE SUSPENSION (HUMALOG MIX 25) VIA A PEN INJECTION DEVICE (HUMAPEN ERGO-OPAQUE CARTRIDGE HOLDER) SINCE 2001. A COUPLE OF MONTHS PRIOR TO THIS REPORT IN 2002 THE PT EXPERIENCED HIGH BLOOD SUGARS FOR TWO WEEKS AND FOR FOUR DAYS THEY HAD KETONES IN THEIR BLOOD. WHEN THE PT STOPPED USING THE PEN AND SWITCHED TO A SYRINGE, THEIR BLOOD SUGARS RETURNED TO NORMAL. THE PT THINKS THAT THE PEN WAS PRIMING OK BUT THEY CAN NOT BE SURE. THE REPORTER STATES THAT THE PT'S CONTROL IS NOT PERFECT BUT USUALLY DOES NOT GET SERIOUS "HYPERS". AT THE TIME OF REPORTING THE PT HAD FULLY RECOVERED AND THE EVENTS HAD ABATED. 25% INSULIN LISPRO SOLUTION/ 75% INSULIN LISPRO PROTAMINE SUSPENSION CONTINUES. THE PEN WILL NOT BE RETURNED FOR FURTHER ANALYSIS AS IT HAS BEEN DISCARDED. FOLLOW-UP WILL BE CONDUCTED TO OBTAIN FUTHER INFO. THE EVENT WAS NOT ASSESSED BY A HEALTH CARE PROFESSIONAL. UPDATE JUN 2002: UPON PHYSICIAN REVIEW IT WAS DECIDED THAT THE CASE SHOULD BE UPGRADED TO OTHER REASON SERIOUS FOR THE EVENT OF KETONES IN THE BLOOD. CASE UPDATED ACCORDINGLY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other