BEUDAMED
    FDA Adverse Event Other Summary report: N

    HUMAPEN ERGO, TEAL/CLEAR

    MDR report key: 822612 · Received February 22, 2007

    Report

    Report Number
    1819470-2007-00010
    Event Type
    Other
    Date Received
    February 22, 2007
    Date of Event
    January 23, 2007
    Report Date
    January 24, 2007
    Manufacturer
    ELI LILLY AND CO
    Product Code
    KZE
    PMA / PMN Number
    HU MKT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROGRESS.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE, REPORTED BY THE DAUGHTER OF THE PT TO A RESPONSIBLE PHARMACIST (NOT A HEALTHCARE PROFESSIONAL), CONCERNS A FEMALE PT OF UNK AGE. THE MEDICAL HISTORY OF THE PT WAS NOT REPORTED. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE PT TOOK AN UNK DOSAGE REGIMEN OF HUMAN INSULIN (HUMULIN, UNSPECIFIED TYPE) VIA A HUMAPEN ERGO TEAL/CLEAR PEN WITH A CLEAR CARTRIDGE HOLDER ATTACHED (LOT NUMBER: 0406A03) FOR THE TREATMENT OF DIABETES MELLITUS BEGINNING ON AN UNK DATE. THE DAUGHTER OF THE PT CALLED THE RESPONSIBLE PHARMACIST DUE TO DEVICE MALFUNCTION. SHE SAID "THE PISTON DOES NOT DISPENSE, NOT ONE DROP COMES OUT, BECAUSE THE PISTON WAS STUCK," THE PT REALIZED THIS TOO LATE, ONCE THE BLOOD SUGAR LEVEL WAS AT 17 (UNITS NOT PROVIDED). THE BLOOD SUGAR LEVEL OF THE PT NORMALIZED THE NEXT DAY. THE PT WAS CALLED UP BUT ONLY THE HUSBAND OF THE PT WAS AT HOME AND HE SAID THE PT WILL BE AVAILABLE AT 0900H. THE NEXT DAY, DURING THIS CALL, HE SAID WHEN THE PT EXPERIENCED HIGH BLOOD SUGAR LEVEL SHE WENT TO THE HEALTHCARE PROFESSIONAL THE DAY OF EVENT. THE HEALTHCARE PROFESSIONAL USED CORRECTIVE TREATMENT AND PRESCRIBED SOMETHING TO THE PT BUT THE HUSBAND COULD NOT REMEMBER IT. THERE IS NO INFO REGARDING CORRECTIVE TREATMENT. THE HUSBAND DID NOT PROVIDE HEALTHCARE PROFESSIONAL DETAILS. THE PT WAS CALLED UP AGAIN WITHIN THE TIMEFRAME THE HUSBAND SUGGESTED. THE PT WAS NOT AT HOME AS THE HUSBAND SAID SHE WENT TO THE HOSP. THE HUSBAND COULD NOT STATE MORE DETAILS CONCERNING WHY THE PT WENT TO HOSP. HE ASKED TO CALLTHE PT BACK AT 1300H. THE PT WAS NOT AVAILABLE. THE CASE WAS REPORTED AS SERIOUS OTHER BECAUSE, ALTHOUGH THE PT WAS NOT HOSPITALIZED FOR THE HIGH BLOOD SUGAR LEVELS, SHE WENT TO THE FAMILY DR WHO TREATED IT. FURTHER INFO WAS NOT AVAILABLE FOR THIS CASE. THE PT USED HUMAPEN ERGO TEAL-CLEAR REUSEABLE PEN. IT WAS UNK WHETHER THE PT OPERATED THE DEVICE OR WHETHER THE OPERATOR WAS A TRAINED USER. THE DEVICE WAS RETURNED TO THE MFR FOR FURTHER INVESTIGATION. ATTEMPTED TO OBTAIN LOT/CONTROL NUMBER FOR THE DRUG, INFO WAS UNK. THIS WAS A NON-HEALTHCARE PROFESSIONAL REPORT AND SO RELATEDNESS WAS NOT STATED. THERE WAS NO INFO REGARDING RELATEDNESS OF THE EVENT TO THE SUSPECT DRUG OR DEVICE DUE TO THE ABSENCE OF HEALTHCARE PROFESSIONAL DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMAPEN ERGO, TEAL/CLEAR PEN INJECTOR FOR TREATMENT PURPOSES KZE ELI LILLY AND CO MS8929 0406A03

    Patients

    Seq Age Sex Outcome Treatment
    1 YR