BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMAPEN ERGO, TEAL/CLEAR

    MDR report key: 492197 · Received October 24, 2003

    Report

    Report Number
    1819470-2003-00035
    Event Type
    Injury
    Date Received
    October 24, 2003
    Date of Event
    September 29, 2003
    Report Date
    September 29, 2003
    Manufacturer
    ELI LILLY AND CO.
    Product Code
    FMF
    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 CASE, REPORTED BY THE PT'S PARTNER, WHO CONTACTED THE CO WITH A PRODUCT COMPLAINT AND TO REPORT AN ADVERSE EVENT. THE PT'S MED HISTORY WAS NOT PROVIDED. THE PT WAS NOT RECEIVING ANY CONCOMITANT MEDICATIONS. THE PT REC'D INSULIN LISPRO (HUMALOG) VIA A HUMAPEN ERGO TEAL/CLEAR PEN BODY (40242) WITH A CLEAR CARTRIDGE HOLDER ATTACHED FOR THE TREATMENT OF DIABETES. NO START DATE OR DOSAGE INFO WAS PROVIDED. IN 2003, WHILST RECEIVING INSULIN LISPRO VIA A HUMAPEN, THE PT WAS ADMITTED TO HOSP IN THE EARLY HOURS OF THE MORNING SUFFERING FROM HYPOGLYCEMIA. THE OPERATOR OF THE DEVICE WAS THE PT AND IT WAS UNK IF THE PT HAD BEEN TRAINED. THE DEVICE WAS BETWEEN 12 MONTHS AND TWO YEARS OLD. NO FURTHER INFO ON THE DEVICE WAS PROVIDED. THE PT WAS DISCHARGED FROM HOSP IN 2003 AND WAS RECOVERING FROM THE HYPOGLYCEMIA. IT WAS UNK IF THERAPY WITH INSULIN LISPRO WAS CONTINUING. THIS HUMAPEN ERGO COMPLAINT IS ASSOCIATED WITH CID00204051.

    Description of Event or Problem · 1

    THIS CASE, REPORTED BY THE PATIENT'S PARTNER, WHO CONTACTED THE COMPANY WITH A PRODUCT COMPLAINT AND TO REPORT AN ADVERSE EVENT, CONCERNS A PATIENT. THE PATIENT'S MEDICAL HISTORY WAS NOT PROVIDED. THE PATIENT WAS NOT RECEIVING ANY CONCOMITANT MEDICATIONS. THE PATIENT RECEIVED INSULIN LISPRO (HUMALOG) VIA A HUMAPEN ERGO TEAL/CLEAR PEN BODY (40242) WITH A CLEAR CARTRIDGE HOLDER ATTACHED FOR THE TREATMENT OF DIABETES. NO START DATE OR DOSAGE INFORMATION WAS PROVIDED. IN 2003, WHILE RECEIVING INSULIN LISPRO VIA A HUMAPEN, THE PATIENT WAS ADMITTED TO HOSPITAL IN THE EARLY HOURS OF THE MORNING SUFFERING FROM HYPOGLYCEMIA. THE OPERATOR OF THE DEVICE WAS THE PATIENT AND IT WAS UNKNOWN IF THE PATIENT HAD BEEN TRAINED. THE DEVICE WAS BETWEEN 12 MONTHS AND TWO YEARS OLD. NO FURTHER INFORMATION ON THE DEVICE WAS PROVIDED. THE PATIENT WAS DISCHARGED FROM HOSPITAL AND WAS RECOVERING FROM THE HYPOGLYCEMIA. IT WAS UNKNOWN IF THERAPY WITH INSULIN LISPRO WAS CONTINUING. THIS HUMAPEN ERGO COMPLAINT IS ASSOCIATED WITH CID00204051. FURTHER INFORMATION WILL BE REQUIRED. THE HYPOGLYCEMIA WAS UNASSESSED BY A HEALTHCARE PROFESSIONAL. THE DEVICE WAS RETURNED TO THE MANUFACTURER. THE DEVICE IS BEING SENT TO THE MANUFACTURER FOR ADDITIONAL EVALUATION AND CONCLUSION IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMAPEN ERGO, TEAL/CLEAR PEN INJECTOR FMF ELI LILLY AND CO. MS8929 40242

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization