BEUDAMED
    FDA Adverse Event Other Summary report: N

    HUMAPEN ERGO, TEAL/OPAQUE

    MDR report key: 406067 · Received July 18, 2002

    Report

    Report Number
    1819470-2002-00025
    Event Type
    Other
    Date Received
    July 18, 2002
    Date of Event
    May 1, 2002
    Report Date
    June 21, 2002
    Manufacturer
    ELI LILLY AND CO.
    Product Code
    KZE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PHARMACETICAL DELIVERY SYSTEMSS PROVIDED DETAILED ANALYSIS RESULTS ON 8/14/2002: THE COMPLAINANT DID NOT RETURN THE DEVICE TO THE MFR FOR INVESTIGATION. THUS IT IS NOT POSSIBLE TO DETERMINE IF THE COMPLAINT DEVICE MALFUNCTION. THE COMPLAINT DESCRIPTION IS INSUFFICIENT TO CONCLUDE THAT A DEVICE MALFUNCTION OCCURRED. UPDATE 7/31/2002: LAB UNITS PROVIDED BY REPORTING HCP FOR LAB DATA. CASE UPDATED ACCORDINGLY. UPDATE 8/14/2002: PHARMACEUTICAL DELIVERY SYSTEMS PROVIDED RESULTS AND CONCLUSION, UPDATES THE NARRATIVE AND THE CIOMS-II FIELD.

    Description of Event or Problem · 1

    THIS DEVICE CASE, REPORTED BY A NON HEALTH CARE PROFESSIONAL WHO CONTACTED THE CO WITH A PRODUCT COMPLAINT WITH FURTHER INFO FROM A HEALTH CARE PROFESSIONAL (HCP), CONCERNS A PT. THE INITIAL REPORTER STATES THAT THE PT WAS DIAGNOSED WITH DIABETES IN OCT-1999. THE REPORTING HCP STATES THAT THE PT HAS HAD DIABETES FOR SIX YRS SINCE 1996. THE PT HAS NO HISTORY OF INTERRUPTION IN INSULIN THERAPY, INTERCURRENT ILLNESS STRESS, RECENT NAUSEA AND VOMITING, FLUID OR ELECTROLYTE DEPLETION, OR OF THE PT FORGETTING TO USE INSULIN. THE PT DID NOT TAKE ANY STEROID THERAPY. IN JAN 2001 THE PT HAD A CHANGE IN THEIR INSULIN THERAPY TO 25% INSULIN LISPRO SOLUTION/ 75% INSULIN LISPRO PROTAMINE SUSPENSION. THE REPORTING HCP STATES THAT THE PT OMITS INSULIN AS PART OF THEIR SELF HARM (JAN-2002). THE PT MEDICAL HISTORY INCLUDES A CHOLECYSTECTOMY IN 1989, APPENDICECTOMY, ASTHMA AND DEPRESSION AND EATING DISORDER (2000 ONWARDS). THE REPORTING HCP STATES THAT THE PT WAS ALSO RECEIVING FLUOXETINE (PROZAC) FOR THE TREATMENT OF RECURRENT DEPRESSION. THE PT HAD BEEN RECEIVING 25% INSULIN LISPRO SOLUTION/ 75% INSULIN LISPRO PROTAMINE SUSPENSION (HUMALOG MIX 25) VIA A PEN INJECTION DEVICE (HUMAPEN ERGO - OPAQUE CARTRIDGE HOLDER) SINCE JAN-2001. IN MAY-2002 THE PT EXPERIENCED HIGH BLOOD SUGARS AND IN JUN 2002 THE PT BLOOD SUGARS WERE 28.7MMOL/LITRE AND THEY HAD KETONES IN THEIR BLOOD. THE PT DID NOT KNOW THEY HAD TO PRIME THE PEN EACH TIME, AND SAID THAT THEIR CLINIC HAD NOT BEEN VERY HELPFUL AS THEY HAD NOT EXPLAINED ANYTHING TO THEM. THE REPORTING HCP DID NOT KNOW OF THIS ADVISE EVENT AND THEREFORE COULD NOT GIVE ANY FURTHER INFO RELATING TO THIS. HOWEVER THE REPORTING HCP DID STATE THAT THE PT HAD POOR CONTROL WHICH WAS RELATED TO THEIR OVEREATING WHEN THE PT IS/WAS DEPRESSED. THE HCP STATES THAT THE FLUOXETINE HAS HELPED THE PT'S DEPRESSION. LAB DATA: JAN-2002 HBA1C LEVEL 9.8%; URINARY KETONES 0.5; UREA 76. AT THE TIME OF REPORTING THE PT HAD NOT RECOVERED AND THE EVENTS WERE CONTINUING. 25% INSULIN LISPRO SOLUTION/75% INSULIN LISPRO PROTAMINE SUSPENSION CONTINUES. THE PEN IS DUE TO BE RETURNED FOR FURTHER ANALYSIS. THE EVENT WAS NOT ASSESSED BY A HCP. UPDATE JUN-2002: UPON PHYSICIAN REVIEW OF THIS CASE THE EVENT OF KETONES IN THE BLOOD SHOULD BE UPGRADED TO OTHER REASON SERIOUS. CASE UPDATED ACCORDINGLY.

    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 33 YR Other