BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMAPEN ERGO, TEAL/CLEAR

    MDR report key: 1001036 · Received February 20, 2008

    Report

    Report Number
    1819470-2008-00007
    Event Type
    Injury
    Date Received
    February 20, 2008
    Date of Event
    January 15, 2008
    Report Date
    January 22, 2008
    Manufacturer
    ELI LILLY AND CO.
    Product Code
    FMF
    PMA / PMN Number
    K982842
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF DEVICE IS RETURNED, EVALUATION WILL BE PERFORMED TO DETERMINE IF A MALFUNCTION HAS OCCURRED. NOTE: THIS IS AN INITIAL REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE FINAL EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

    THIS DEVICE CASE, REPORTED BY A CONSUMER, WHO CONTACTED THE COMPANY WITH A PRODUCT COMPLAINT, CONCERNS A MALE PATIENT OF UNKNOWN ORIGIN. THE PATIENT'S MEDICAL HISTORY WAS NOT PROVIDED. CONCOMITANT MEDICATIONS INCLUDED LEVOTHYROXINE SODIUM TAKEN SINCE SEVEN YEARS AGO (2001) FOR AN UNSPECIFIED THYROID DISORDER. THE PATIENT WAS TAKING INSULIN LISPRO 25%, 75% NPL (HUMALOG MIX 25), 26 UNITS IN THE MORNING AND 47 UNITS IN THE EVENING, ROUTE OF ADMINISTRATION NOT REPORTED, FOR THE TREATMENT OF DIABETES, BEGINNING ON AN UNKNOWN DATE SEVEN YEARS AGO (2001). IN 2008, TIME OF EVENT ONSET UNKNOWN AFTER BEGINNING INSULIN LISPRO 25%, 75% NPL VIA A HUMAPEN ERGO TEAL/CLEAR (LOT NUMBER NOT REPORTED), THE PATIENT EXPERIENCED HIGH BLOOD SUGARS. THE CONSUMER BELIEVED THE PLUNGER IN THE PEN WAS NOT FUNCTIONING PROPERLY AND WAS NOT PUSHING OUT THE CORRECT DOSE. THE PATIENT BLOOD SUGARS WERE USUALLY BELOW 10, BUT HAD GONE UP TO BETWEEN 16 AND 23 (NO UNITS PROVIDED). THE PATIENT BELIEVED THAT HE WAS ONLY GETTING ABOUT A THIRD OF THE AMOUNT OF INSULIN DIALED UP. NO OTHER RELEVANT PATIENT PHYSICAL FINDINGS WERE REPORTED. IT WAS UNKNOWN WHETHER THE PATIENT RECEIVED ANY CORRECTIVE TREATMENT FOR THE EVENT, AND THE PATIENT FULLY RECOVERED FROM THE EVENT ON 21-JAN-2008. INSULIN LISPRO 25%, 75% NPL TREATMENT WAS BEING CONTINUED. THE HUMAPEN ERGO TEAL/CLEAR COMPLAINT IS ASSOCIATED WITH ANOTHER DEVICE. IT WAS UNKNOWN WHO THE OPERATOR OF THE DEVICE WAS AND IF THE OPERATOR OF THE DEVICE WAS A TRAINED USER. THE PATIENT HAD BEEN USING THE DEVICE MODEL SINCE SEVEN YEARS AGO (2001). IF THE DEVICE IS RETURNED, AN EVALUATION WILL BE PERFORMED TO DETERMINE IF A MALFUNCTION OCCURRED. THE PATIENT WAS CONTINUING TO USE THE HUMAPEN ERGO TEAL/CLEAR. SINCE THIS CASE WAS REPORTED BY A CONSUMER, NO OPINION OF RELATEDNESS BETWEEN THE EVENT AND INSULIN LISPRO 25%, 75% NPL TREATMENT OR BETWEEN THE EVENT AND THE DEVICE WAS REPORTED. UPDATE 29-JAN-2008: CASE LINKED WITH CATOOL AND GID AND CID NUMBERS ENTERED IN PRODUCT TAB.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other