BEUDAMED
    FDA Adverse Event Other Summary report: N

    HUMAPEN ERGO, BURG/CLEAR

    MDR report key: 446705 · Received March 3, 2003

    Report

    Report Number
    1819470-2003-00004
    Event Type
    Other
    Date Received
    March 3, 2003
    Report Date
    January 24, 2003
    Manufacturer
    ELI LILLY AND CO.
    Product Code
    KZE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS USING INSULIN LISPRO (HUMALOG), FOUR TIMES A DAY (10, 6, 12 AND 4 UNITS) FOR DIABETES VIA A PEN INJECTOR DEVICE (HUMAPEN ERGO BURGUNDY/CLEAR, LOT# UNKNOWN). THE PATIENT REPORTED THAT THIS WAS THE SECOND HUMAPEN THAT HAS BEEN FAULTY IN A FEW MONTHS. THIS HUMAPEN IS NOT CLICKING WHEN DIALING AND THERE IS SOMETHING STICKY IN THE PEN. THEY HAVE NEVER HAD A CRACKED CARTRIDGE AND THEY DO NOT STORE IT IN THE FRIDGE. IN 2003, THEIR BLOOD SUGAR WAS HIGH AND THEY WERE NOT SURE IF THEY GOT THEIR INSULIN. THEIR BLOOD SUGAR LEVELS ROSE TO 18 (MMOL/LITRE) AND THEY ARE USUALLY 8-9 (MMOL/LITRE). THE PATIENT ALSO USES ANOTHER HUMAPEN (UNKNOWN TYPE) TO ADMINISTER HUMAN INSULIN ISOPHANE SUSPENSION (HUMULIN N). THE DEVICE COMPLAINT IS ASSOCIATED WITH CID165435. THE RETURN OF THE DEVICE IS ANTICIPATED. UPON FOLLOW-UP WITH THE PATIENT, IN 2003, THE PATIENT SUBSEQUENTLY REPORTED THAT THEY ALSO HAD PROBLEMS WITH THEIR FIRST HUMAPEN (HUMAPEN ERGO BURGUNDY/CLEAR, LOT NUMBER UNKNOWN). THE PATIENT HAD TAKEN THEIR INSULIN, INJECTED AND THOUGHT THEY RECEIVED THEIR DOSE. LATER, AS THEY WERE MONITORING THEIR GLUCOSE, THEY NOTICED THEIR BLOOD SUGARS GOING HIGHER AND HIGHER. IT WAS THEN THAT THEY REALIZED THAT IT WAS THE PEN WHICH WAS THE PROBLEM. THE PATIENT WAS HOSPITALIZED AND THEY BELIEVES THAT THEY DID NOT RECEIVE THEIR DOSE. THE PATIENT NO LONGER HAS THIS DEVICE AS THEY RETURNED IT TO THEIR PHARMACY. THIS DEVICE COMPLAINT IS ASSOCIATED WITH CID16577. THIS DEVICE WILL NOT BE RETURNED (AS THE PHARMACY DOES NOT RECALL THE INCIDENT). THE PATIENT WAS THE OPERATOR OF THE DEVICE BUT IT IS UNKNOWN WHETHER THEY WERE TRAINED. DURATION OF USE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMAPEN ERGO, BURG/CLEAR PEN INJECTOR KZE ELI LILLY AND CO. MS8930 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Hospitalization BRAND: HUMAPEN ERGO 3 ML TYPE: PEN INJECTOR