BEUDAMED
    FDA Adverse Event Other Summary report: N

    HUMAPEN ERGO 3 ML

    MDR report key: 374959 · Received February 1, 2002

    Report

    Report Number
    1819470-2002-00005
    Event Type
    Other
    Date Received
    February 1, 2002
    Report Date
    January 7, 2002
    Manufacturer
    ELI LILLY AND CO.
    Product Code
    KZE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS DEVICE CASE, THE SECOND OF TWO REPORTED BY A DIABETES SPECIALIST NURSE, CONCERNS A PATIENT WHO EXPERIENCED DIABETIC KETOACIDOSIS (DKA) REQUIRING HOSPITALIZATION. THE PATIENT WAS USING A PEN INJECTION DEVICE (HUMAPEN ERGO-UNKNOWN CARTRIDGE HOLDER TYPE) TO DELIVER 30% SOLUBLE INSULIN/70% ISOPHANE INSULIN (HUMULIN M3) FOR THE TREATMENT OF TYPE I DIABETES. THE PATIENT DID NOT HAVE ANY RELEVANT MEDICAL HISTORY. THE PATIENT WAS NOT TAKING ANY CONCOMITANT MEDICATION. THE PATIENT WAS USING THE PEN INJECTION DEVICE WHEN PATIENT EXPERIENCED DKA A COUPLE OF DAYS PRIOR TO THE REPORT (IN 2002) AND WAS ADMITTED TO HOSPITAL. THE REPORTER STATED THE PATIENT WAS IN AND OUT OF HOSPITAL WITH DKA OVER THE LAST FEW MONTHS PRIOR TO THE REPORT. THE REPORTER STATED THAT THE PATIENT HAS STARTED TO EXPERIENCE DKA SINCE PATIENT STARTED TO USE THE PEN INJECTION DEVICE. WHEN THE PATIENT WAS IN HOSPITAL A COUPLE OF DAYS PRIOR TO THE REPORT, THE REPORTER WATCHED THE PATIENT INJECT INSULIN USING THE PEN INJECTION DEVICE. THE REPORTER IDENTIFIED THAT THE PATIENT WAS USING THE PEN INJECTION INCORRECTLY. THE PATIENT HAD BEEN WINDING THE DIAL DOWN TO ZERO TO INJECT THE INSULIN AND THOUGHT THE INSULIN HAD BEEN DELIVERED. THE REPORTER STATED THE PATIENT WAS USING THE PEN INCORRECTLY AS PATIENT HAD BEEN GIVEN THE PEN INJECTION DEVICE BY A PHARMACIST, AND HAD NOT BEEN SHOWN THE CORRECT TECHNIQUE BY A DIABETES NURSE. 30% SOLUBLE INSULIN/70% ISOPHANE INSULIN WAS DISCONTINUED AND USE OF THE PEN INJECTION DEVICE WAS DISCONTINUED. THE PATIENT WAS SWITCHED TO THE 25% INSULIN LISPRO/75% INSULIN LISPRO PROTAMINE SUSPENSION PRE-FILLED PEN. THE PATIENT HAS NOW FULLY RECOVERED. THE REPORTER CONSIDERS THE PATIENT EVENT TO BE RELATED TO USER ERROR OF THE PEN INJECTION DEVICE. THE REPORTER DOES NOT CONSIDER THE PATIENT EVENT TO BE RELATED TO EITHER 30% SOLUBLE INSULIN/70% ISOPHANE INSULIN OR THE PEN INJECTION DEVICE. THE PEN IS UNAVAILABLE FOR EXAMINATION AND THE REPORTER DOES NOT HAVE ANY FURTHER INFORMATION. UPDATE JAN-2002: PRELIMINARY REPORT PREPARED FOR SUBMISSION TO MEDICAL DEVICES AGENCY.

    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