BEUDAMED
    FDA Adverse Event Other Summary report: N

    HUMAPEN ERGO, TEAL/CLEAR

    MDR report key: 412096 · Received August 16, 2002

    Report

    Report Number
    1819470-2002-00031
    Event Type
    Other
    Date Received
    August 16, 2002
    Date of Event
    July 1, 2002
    Report Date
    July 18, 2002
    Manufacturer
    ELI LILLY AND CO.
    Product Code
    KZE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    THIS DEVICE CASE, REPORTED BY A NON-HEALTH CARE PROFESSIONAL, WHO CONTACTED THE CO TO MAKE A PRODUCT COMPLAINT. THE PT WAS USING A PEN INJECTION DEVICE (HUMAPEN ERGO/CLEAR CARTRIDGE HOLDER) TO DELIVER SOLUBLE INSULIN (HUMULIN S) FOR THE TREATMENT OF DIABETES. THE PT WAS ALSO TAKING ISOPHANE INSULIN (HUMULIN I) AND NO OTHER CONCOMITANT MEDICATION. THE PT'S MEDICAL HISTORY INCLUDED A LONG HISTORY OF DIABETES WITH NORMAL BLOOD GLUCOSE READING OF FIVE TO SIX. THE PT COMMENCED USING THE PEN INJECTION DEVICE IN JAN 2002 TO DELIVER SOLUBLE INSULIN (HUMULIN S), 22 UNITS IN THE MORNING, 24 UNITS AT LUNCH AND 24 UNITS IN THE EVENING. WHILE USING THE PEN INJECTION DEVICE THE PT EXPERIENCED RAISED BLOOD GLUCOSE, HYPOGLYCEMIA AND A CAR CRASH. ONE WEEK PRIOR TO THE REPORT (JUL-2002), SIX MONTHS AFTER PT HAD STATED USING THE HUMAPEN ERGO-CLEAR CARTRIDGE HOLDER THE PT EXPERIENCED RAISED BLOOD GLUCOSE. THE REPORTER STATED THAT WHEN THE PT WAS SELF INJECTING THEY FELT THE PEN 'SLIPPING. THE REPORTER STATED THE PT MADE THE ASSUMPTION TO HAVE NOT RECEIVED ANY INSULIN AND GAVE SELF ANOTHER INJECTION OF 22 UNITS WITHOUT TESTING BLOOD SUGARS. THE REPORTER SAID THE PT MAY HAVE RECEIVED UP TO 44 UNITS OF SOLUBLE INSULIN IN TOTAL. THE REPORTER STATED THAT ON THE WAY HOME FROM WORK THE PT EXPERIENCED A HYPOGLYCEMIC ATTACK AND HIT SEVERAL CARS. THE PT HURT THEIR HANDS IN THE PROCESS. THE MANUFACTURER CONSIDERED THE EVENT OF A CAR CRASH TO BE SERIOUS. INITIAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE GENERAL CONDITION OF THE PEN WAS GOOD BUT THAT THE LEAD SCREW IS JAMMED AND WILL NOT RETRACT THE PT FULLY RECOVERED FROM THE HYPOGYCEMIA IN 2002. THE PT CONTINUES TO TAKE SOLUBLE INSULIN. FURTHER INF HAS BEEN REQUESTED. THE EVENTS ARE UNASSESSED BY A HEALTH CARE PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMAPEN ERGO, TEAL/CLEAR PEN INJECTOR KZE ELI LILLY AND CO. MS8929 40093

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other