BEUDAMED
    FDA Adverse Event Other Summary report: N

    HUMAPEN ERGO, TEAL/OPAQUE

    MDR report key: 466716 · Received June 11, 2003

    Report

    Report Number
    1819470-2003-00019
    Event Type
    Other
    Date Received
    June 11, 2003
    Report Date
    May 12, 2003
    Manufacturer
    ELI LILLY AND CO
    Product Code
    KZE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    THIS DEVICE CASE, WHICH INVOLVES AN ADVERSE EVENT, REPORTED BY THE MOTHER OF A CONSUMER, CONCERNS A PT WHO EXPERIENCED HIGH BLOOD SUGAR LEVELS AND HEADACHES. THE PT WAS TAKING ISOPHANE (HUMULIN NPH) AND LISPRO (HUMALOG), DOSE UNK, VIA A HUMAPAN ERGO (TEAL WITH OPAQUE CARTRIDGE) DEVICE FOR TREATMENT OF INSULIN DEPENDANT DIABETES MELLITUS. THE CONSUMER OPERATED THE DEVICE. IT IS UNKNOWN IF THE CONSUMER WAS A TRAINED USER OR HOW LONG THEY HAD USED THE DEVICE. THE PT'S MEDICAL HISTORY INCLUDED A DIAGNOSIS OF DIABETES AT THE AGE OF TWELVE. THE PT IS NOT TAKING ANY CONCOMITANT MEDICATIONS. IN 5/2003, 3 YEARS AFTER BEGINNING AN ISOPHANE (HUMULIN NPH) VIA THE HUMAPEN ERGO TEAL OPAQUE CARTRIDGE MS8335, THE PT EXPERIENCED HIGH SUGAR LEVELS (HIGH 30S) AND HEADACHES. THE PT HAD BEEN EATING NORMALLY AND OVER A PERIOD OF THREE DAYS EXPERIENCED RAISED BLOOD SUGAR LEVELS. THE SHORT ACTING LISPRO BROUGHT THE SUGAR LEVELS DOWN TEMPORARILY. THE PT WAS NOT PRODUCING KETONES IN THE URINE. ON THE THIRD DAY, THE PT WAS USING THE PEN AND INSULIN DRIP ONTO THE HAND. THE MOTHER OF THE PT THREW THE PEN AWAY AND THE DIABETES ASSOCIATION ISSUED ANOTHER, THE PT ALSO OBTAINED A NEW PEN FROM THE OUTPATIENT CLINIC. THE MOTHER OF THE PT STATED THAT THE HUMAPEN ERGO WAS CRACKED AND THREW THE PEN AWAY; THEREFORE, NO PEN WILL BE AVAILABLE FOR EVAL. TREATMENT WITH THE INSULIN IS CONTINUING AND USE WITH THE HUMAPEN ERGO IS CONTINUING. THE PT HAS FULLY RECOVERED FROM THE HEADACHES AND HIS BLOOD SUGAR LEVELS HAVE RETURNED TO NORMAL. THIS CASE IS UNASSESSED FOR CAUSALITY AS THE REPORTER WAS NOT A HEALTH CARE PROFESSIONAL. THIS REPORT IS CROSS-REFERENCED WITH "CID" 180755. UPDATED DEVICE SERIOUS OUTCOMES TO SERIOUS FOR OTHER. ADDED PT'S HISTORY TO RELEVANT HISTORY FIELD. VERY HIGH BLOOD GLUCOSE.

    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 15 YR Other