BEUDAMED
    FDA Adverse Event Other Summary report: N

    HUMAPEN ERGO, BURGUNDY/CLEAR

    MDR report key: 799444 · Received December 21, 2006

    Report

    Report Number
    1819470-2006-00030
    Event Type
    Other
    Date Received
    December 21, 2006
    Date of Event
    December 2, 2006
    Report Date
    December 4, 2006
    Manufacturer
    ELI LILLY AND CO
    Product Code
    KZE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IF DEVICE IS RETURNED, EVALUATION WILL BE PERFORMED TO DETERMINE IF A MALFUNCTION HAS OCCURRED.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE, REPORTED BY A CONSUMER VIA A COMPLAINT ASSISTANT, CONCERNS A FEMALE PATIENT. THE PT'S MEDICAL HISTORY INCLUDED SOME KIND OF HEART DISEASE (THE PT COULD NOT SPECIFY IT) AND VASCULAR DEMENTIA (THE PATIENT COULD NOT PROVIDE EXACT DATES) AND DIABETES MELLITUS FROM 1993, SHE STARTED ANTIDIABETIC THERAPY AT THIS TIME. CONCOMITANT MEDICATIONS WERE PROVIDED AS FOLLOWS; VINPOCETINE FOR VASCULAR DEMENTIA, METOPROLOL TARTRATE FOR HEART DISEASE, AND THE FOLLOWING ANTIDIABETICS FOR DIABETES MELLITUS; METFORMIN HYDROCHLORIDE, ACARBOSE, AND GLIBENCLAMIDE. THE PT TOOK HUMAN REGULAR INSULIN (HUMULIN R, 12IU AT 22:00HOURS) VIA A HUMAPEN ERGO BURGUNDY/CLEAR PEN BODY (LOT 0410A01) WITH A CLEAR CARTRIDGE HOLDER ATTACHED FOR THE TREATMENT OF DIABETES MELLITUS BEGINNING IN 2005. IN 2006, APPROX ONE YEAR AND SIX MONTHS AFTER STARTING HUMAN REGULAR INSULIN, THE PT REPORTED THE INSULIN DID NOT COME OUT OF THE PEN. AT NIGHT AND IN THE MORNING,THE PT'S BLOOD SUGAR LEVEL WAS HIGHER THAN USUAL: 16-18 MMOL/L. THE PT'S BLOOD SUGAR LEVEL WAS 7.6 MMOL/L IN GENERAL. THE FASTING VALUE OF BLOOD GLUCOSE LEVEL WAS 14 MMOL/L. NO OTHER RELEVANT PHYSICAL FINDINGS WERE PROVIDED. CORRECTIVE TREATMENT WAS UNK, ALTHOUGH THE CASE WAS REPORTED AS SERIOUS BECAUSE THE PT RECEIVED OUTPATIENT THERAPY. THE PT OUTCOME WAS UNK AND HUMAN REGULAR INSULIN WAS DISCONTINUED AFTER ONE YEAR AND 6 MONTHS. THIS HUMAPEN ERGO BURGUNDY/CLEAR PEN BODY COMPLAINT IS ASSOCIATED WITH CID00459135. THE OPERATOR OF THE DEVICE WAS UNK, AND IT WAS UNK IF THE OPERATOR OF THE DEVICE WAS TRAINED. IT WAS UNK HOW LONG THE PT HAD USED THE DEVICE. THE PT PLANNED TO BRING THE DEVICE TO THE MFR, THEREFORE, THIS PARTICULAR DEVICE WOULD BE DISCONTINUED. ATTEMPTED TO OBTAIN LOT/CONTROL NUMBER; INFO WAS UNK. AS THIS WAS A CONSUMER REPORT, CAUSALITY WAS NOT ASSESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMAPEN ERGO, BURGUNDY/CLEAR PEN INJECTOR FOR TREATMENT PURPOSES KZE ELI LILLY AND CO MS8930 041A01

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other GLUCOBAY/GFR/(ACARBOSE)UNK| METFORMINE "MERICK (METFORMIN HYDROCHLORIDE)UNK| CAVINTON (VINPOCETINE)UNK| GLUCOBENE (GLIBENCLAMIDE)UNK| BETALOC (METOPROLOL TARTRATE)UNK