BEUDAMED
    FDA Adverse Event Other Summary report: N

    HUMAPEN ERGO, BURG/CLEAR

    MDR report key: 359829 · Received November 1, 2001

    Report

    Report Number
    1819470-2001-00055
    Event Type
    Other
    Date Received
    November 1, 2001
    Date of Event
    October 1, 2000
    Report Date
    October 9, 2001
    Manufacturer
    ELI LILLY AND COMPANY
    Product Code
    KZE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE PT EXPERIENCED THE TWO HYPOGLYCAEMIC COMAS WHILE USING 25% INSULIN LISPRO/75% INSULIN LISPRO PROTAMINE SUSPENSION (HUMALOG MIX 25).

    Description of Event or Problem · 1

    THIS DEVICE CASE, REPORTED BY A NON-HEALTH CASE PROFESSIONAL, CONCERNS A PATIENT WHO EXPERIENCED A HYPOGLYCAEMIC COMA. A SECOND COMA AND BLOOD GLUCOSE ALL OVER THE PLACE. THE PATIENT WAS USING A PEN INJECTION DEVICE (HUMAPEN ERGO - BURGENDY/CLEAR CARTRIDGE HOLDER) TO DELIVER INSULIN LISPRO (HUMALOG) FOR THE TREATMENT OF DIABETES. THE PATIENTS MEDICAL HISTORY INCLUDED LOTS OF UNSPECIFIED COMPLICATIONS INCLUDING MALABSORPTION SYNDROME. THE PATIENTS CONCOMITANT MEDICATION INCLUDED ISOPHANE INSULIN (HUMULIN I) FOR DIABETES AND PANCREATIN (CREON). THE PATIENT COMMENCED USING THE PEN INJECTION DEVICE TO DELIVER INSULIN LISPRO (12/8/10/4 UNITS) IN 1999. ON OCT-2000 THE PATIENT EXPERIENCED A HYPOGLYCAEMIC COMA AND WAS HOSPITALIZED. THE PATIENT WAS UNCONSIOUS FOR APPROXIMATELY FOUR HOURS AND IT MAY HAVE INVOLVED A SEIZURE. THE PT HAD FULLY RECOVERED 9 DAYS LATE AND WAS DISCHARGED FROM HOSPITAL. THE FOLLOWING DAY THE PT EXPERIENCED A SECOND COMA AND WAS ADMITTED TO HOSPITAL. PT WAS UNCONSCIOUS FOR SIX HOURS. THE REPORTER STATED THE PT'S BLOOD CLUCOSE WAS 11. THE PT HAD FULLY RECOVERED 8 DAYS LATE, AND THEY WERE DISCHARGED FROM HOSPITAL. ON AUG-2001 THE PT EXPERIENCED BLOOD GLUCOSE ALL OVER THE PLACE. THE REPORTER STATED THE PATIENT'S BLOOD GLUCOSE HAS BEEN FROM 3.0 TO 20.1. THE PATIENT WAS TOLD BY THEIR DOCTOR TO REDUCE EACH INSULIN INJECTION BY 4 UNITS. THE PATIENT THEN REALIZED THE PEN THEY WERE USING (LOT NUMBER: A1503) HAD NOT BEEN DELIVERING OR PRIMING AND SO THEY STOPPED USING IT. THIS WAS THEIR SECOND PEN, THE FIRST HAVING BEEN DISCARDED. THE REPORTER STATED THE PEN WAS NOT WELL DESIGNED TO GRIP EASILY AND THE PATIENT FOUND IT TOO SLIPPERY, ESPECIALLY AS THE PATIENTS FINGERS HAD BEEN HARDENED BY BLOOD SUGAR TESTING. THE PATIENT IS NOW ON THEIR THIRD HUMAPEN ERGO. INSULIN LISPRO CONTINUES. THE PT HAD FULLY RECOVERED FROM BLOOD GLUCOSE ALL OVER THE PLACE AND THE TWO COMAS THEY HAD EXPERIENCED. THE EVENTS ARE UNSASSESSED BY A HEALTH CARE PROFESSIONAL. THE PEN IS TO BE RETURNED. FURTHER INFORMATION HAS BEEN REQUESTED. UPDATE 18-OCT-2001: PRELIMINARY RECEIVED FROM MANUFACTURER (PHARMACEUTICAL DELIVERY SYSTEMS) ON OCT-2001. PRELIMINARY REPORT PREPARED.

    Description of Event or Problem · 1

    THE PT EXPERIENCED THE TWO HYPOGLYCAEMIC COMAS WHILE USING 25% INSULIN LISPRO/75% INSULIN LISPRO PROTAMINE SUSPENSION (HUMALOG MIX 25) AND PT WAS TAKING ISOPHANE INSULIN BOTH FOR THE TREATMENT OF DIABETES. AND THE PT DOES NOT GET WARNING SYMPTOMS OF IMPENDING HYPOGLYCAEMIA. THE GENERAL PRACTITIONER STATED THE PT WAS USING 25% INSULIN LISPRO/75% INSULIN LISPRO PROTAMINE SUSPENSION TWICE A DAY WHEN THE PT EXPERIENCED BOTH HYPOGLYCAEMIC COMAS. THE PT WAS ADMITTED TO HOSP ON 10/2000, A BIT CONFUSED AND DISORIENTED WITH A HISTORY OF POSSIBLE CHEST INFECTION OVER THE PRCEDING DAYS. ON ADMISSION THE PTS BLOOD GLUCOSE WAS 17.5. THE PT WAS THOUGHT TO HAVE BEEN TREATED BY THE PARAMEDICS WITH A GLUCAGON INJECTION PRIOR TO ADMISSION. THE INITIAL REPORTER STATED THAT ON 10/2000. THE INITIAL REPORTER STATED THAT THE PT HAD FULLY RECOVERED ON 10/2000. TWO WEEKS LATER, THE PT WAS FOUND IN A COMATOSE STATE AT HOME BY HIS MOTHER. THE PT WAS TREATED BY PARAMEDICS WITH A GLUCAGON INJECTION PRIOR TO TRANSFER TO CASUALTY. ON ADMISSION TO HOSP THE PTS BLOOD GLUCOSE WAS 26. THERE WAS NO RECORD OF WHETHER A BLOOD GLUCOSE MEASUREMENT HAD BEEN TAKEN PRIOR TO THE GLUCAGON INJECTION, SO THERE WAS NO CONFIRMATION OF THE HYPOGLCAEMIS STATE. THE GENERAL PRACTITIONER STATED THAT WHILST IN HOSP FOLLOWING THE SECOND EPISODE OF HYPOGLYCAEMIC COMA THE PTS INSULIN REGIMEN WAS CHANGED TO INSUIN LISPRO INJECTIONS BEFORE MEALS AND ISOPHANE INSULIN AT NIGHT TIME. WHILE U SING PEN INJECTION DEVICE TO DELILVER INSULIN LISPRO AND TAKING ISOPHANE INSULIN. THE GP STATED THE PT SEEMS TO TAKE THEIR INSULIN REGULARLY AND IS DILIGENT IN MONITORING THEIR OWN BLOOD GLUCOSE AT HOME, BUT DESPITE THIS THE PT FINDS IT HARD TO ACHIEVE GOOD BLOOD GLUCOSE CONTROL AND PT EXPERIENCES CONSIDERABLE SWINGS IN PT'S BLOOD GLUCOSE. THE PTS MOST RECENT HBA1C RECORDING ON 7/27/2001 WAS 10.3%. THE GP DID NOT PROVIDE AN OPINION ON THE CAUSALITY OF THE EVENT. TO CLARIFY DATES OF DRUG THERAPY AND EVENT DATES. UPDATE 11/2001: FURTHER INFO RECEIVED FROM GENERAL PRACTITIONER. CONTACT DETAILS; EVENT DETAILS; DRUG THERAPY DETAILS; MEDICAL HISTORY LAB VALUES. CONFLICTING INFO GIVEN. THEREFORE CASE UPDATED WITH INFO PROVIDED BY HCP. UPDATE: FURTHER INFO RECEIVED FROM GP. CONTACT DETAILS. RESULTS AND CONCLUSIONS RECEIVED FROM PHARMACEUTICAL DELIVERY SYSTEMS. FINAL REPORT PREPARED FOR SUBMISSION TO MEDICAL DEVICES AGENCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48900 HUMAPEN ERGO, BURG/CLEAR PEN INJECTOR KZE ELI LILLY AND COMPANY MS8930 A1503

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Hospitalization