BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMAPEN ERGO, TEAL/OPAQUE

    MDR report key: 384232 · Received March 21, 2002

    Report

    Report Number
    1819470-2002-00009
    Event Type
    Injury
    Date Received
    March 21, 2002
    Report Date
    February 27, 2002
    Manufacturer
    ELI LILLY AND CO.
    Product Code
    KZE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS DEVICE CASE, WHICH INVOLVES AN ADVERSE EVENT, REPORTED BY A SALES REP, CONCERNS A PT WHO EXPERIENCED KETOSIS. THE PT WAS TAKING AN UNSPECIFIED MEDICATIION VIA A HUMAPEN ERGO DEVICE FOR TREATMENT OF DIABETES. THE DEVICE WAS OPERATED BY THE CONSUMER. IT IS UNKNOWN IF THE CONSUMER WAS A TRAINED USER OR HOW LONG THEY HAD USED THE DEVICE FOR. THE PT'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS ARE UNKNWON. IN JAN-2002, AFTER BEGINNING AN UNSPECIFIED DRUG VIA THE HUMAPEN ERGO (MS8335/MODEL NUMBER UNKNOWN, LOT NUMBER A1409), THE PT FOUND THAT THE LEAD SCREW OF THE HUMAPEN DID NOT WORK VERY WELL (ALWAYS ONE WEEK AFTER BEGINNING USING THE HUMAPEN, THE PT'S FAMILY MEMBER FOUND THE VOLUME OF INSULIN IN THE CARTRIDGE WAS JUST THE SAME AS THE WEEK BEFORE. THE PT WAS DIAGNOSED WITH KETOSIS AND LATER HOSPITALIZED. NO OTHER INFORMATION WAS PROVIDED. IT IS UNKNOWN IF THE UNSPECIFIED DRUG WAS CONTINUED OR DISCONTINUED. IT IS ALSO UNKNOWN IF USE OF THE HUMAPEN ERGO WAS CONTINUED OR DISCONTINUED. THE PT OUTCOME IS UNKNOWN. THIS CASE IS UNASSESSED FOR CAUSALITY AS THE REPORTER WAS NOT A HEALTH CARE PREOFESSIONAL. A PRELIMINARY REPORT HAS NOT BEEN PROVIDED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMAPEN ERGO, TEAL/OPAQUE PEN INJECTOR KZE ELI LILLY AND CO. MS8335 A1409

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Hospitalization