BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMAPEN LUXURA CHAMPAGNE

    MDR report key: 5573206 · Received April 13, 2016

    Report

    Report Number
    1819470-2016-00091
    Event Type
    Injury
    Date Received
    April 13, 2016
    Date of Event
    March 30, 2016
    Report Date
    March 31, 2016
    Manufacturer
    ELI LILLY AND COMPANY
    Product Code
    FMF
    PMA / PMN Number
    K142518
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO REPORTED COMPLAINT FOR THIS DEVICE AND ITS RETURN IS NOT EXPECTED. THIS IS AN INITIAL REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE FINAL EVALUATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    NEW, UPDATED AND CORRECTED INFORMATION IS REFERENCED WITHIN THE UPDATE STATEMENTS. NO FURTHER FOLLOW UP IS PLANNED. EVALUATION SUMMARY THE PATIENT EXPERIENCED HIGH BLOOD GLUCOSE AND WAS TAKEN TO THE EMERGENCY ROOM FOR TREATMENT WHILE USING A HUMAPEN LUXURA (LOT 1305B09). THERE WAS NO PRODUCT COMPLAINT FOR THE DEVICE AND IT WAS NOT RETURNED FOR INVESTIGATION. THERE WAS EVIDENCE OF IMPROPER USE OF THE DEVICE. IT WAS REPORTED THAT THE PATIENT RE-USED NEEDLES. THIS IS LIKELY NOT RELEVANT GIVEN THAT THERE WAS NO PRODUCT COMPLAINT RELATIVE TO PEN FUNCTION. THE DEVICE USER MANUAL INDICATES A NEW NEEDLE SHOULD BE USED WITH EACH INJECTION.

    Description of Event or Problem · 1

    (B)(4) THIS SOLICITED CASE, REPORTED BY A CONSUMER, REGARDING A PATIENT WHO TOOK PART OF A PATIENT SUPPORT PROGRAM (PSP), CONCERNS A (B)(6) BLACK MALE PATIENT. THE MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE PATIENT RECEIVED INSULIN LISPRO 25%LISPRO+75%NPL (HUMALOG MIX25) VIA HUMAPEN LUXURA CHAMPAGNE, 8IU IN THE MORNING, 12IU AT LUNCH AND 10 IU AT NIGHT, SUBCUTANEOUSLY, FOR DIABETES TREATMENT AND BEGINNING ON AN UNSPECIFIED DATE. ON (B)(6) 2016, UNKNOWN TIME AFTER STARTED INSULIN LISPRO 25%LISPRO+75%NPL, THE PATIENTS DIABETES WAS 380 (UNKNOWN UNITS AND REFERENCE RANGE), SO HE APPLIED THE INSULIN; HOWEVER WHEN HE MEASURED THE GLYCEMIA HE NOTED IT WAS 595 AND BECAUSE OF THIS HE WAS TAKEN TO THE EMERGENCY CARE UNIT (UPA). IN THE EMERGENCY CARE UNIT HE RECEIVED INSULIN REGULAR TO NORMALIZE THE BLOOD GLUCOSE AND THE OUTCOME WAS NOT PROVIDED. THE GLYCEMIA OF 595 WAS CONSIDERED AS SERIOUS BY THE COMPANY DUE TO MEDICALLY SIGNIFICANT REASONS. IT WAS REPORTED THE PATIENTS FATHER WENT TO A LECTURE IN WHICH THE COMPANY'S GUIDING INSTRUCTED TO STORE THE IN-USE CARTRIDGE OF INSULIN AT ROOM TEMPERATURE, BUT NOWADAYS HE WAS LIVING IN A WARM WEATHER CITY AND THE TREATING PHYSICIAN INSTRUCTED HIM TO STORE IN THE REFRIGERATOR. THE GLYCEMIC EVENT OCCURRED DURING THE USE OF THE CARTRIDGE OF INSULIN LISPRO 25%LISPRO+75%NPL (LOT C382212C), WHICH WERE STORED ACCORDING TO COMPANY'S GUIDING INSTRUCTIONS. IN ADDITION, IT WAS REPORTED THE PATIENT STORED THE PEN AT ROOM TEMPERATURE, PRIMED THE PEN AND ALWAYS REUSED NEEDLES. THE INSULIN LISPRO 25%LISPRO+75%NPL WAS CONTINUED. THE PATIENT OPERATED THE DEVICE AND HE WAS TRAINED BY THE COMPANY'S GUIDING. THE PATIENT USED THIS DEVICE MODEL AND THE REPORTED DEVICE FOR UNKNOWN TIME. THERE WAS NO REPORTED COMPLAINT FOR THIS DEVICE AND ITS RETURN IS NOT EXPECTED. THE CONSUMER REPORTER DID NOT PROVIDE ANY RELATEDNESS OPINION. UPDATE 06APR2016: UPON REVIEW, THIS CASE WAS OPENED TO UPDATE THE MEDWATCH AND EUROPEAN AND CANADIAN REQUIRED DEVICE REPORTING ELEMENTS FOR REGULATORY REPORTING.

    Description of Event or Problem · 1

    (B)(4). THIS SOLICITED CASE, REPORTED BY A CONSUMER, REGARDING A PATIENT WHO TOOK PART OF A PATIENT SUPPORT PROGRAM (PSP), CONCERNS A (B)(6) BLACK MALE PATIENT. THE MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE PATIENT RECEIVED INSULIN LISPRO 25%LISPRO+75%NPL (HUMALOG MIX25) VIA HUMAPEN LUXURA CHAMPAGNE, 8IU IN THE MORNING, 12IU AT LUNCH AND 10 IU AT NIGHT, SUBCUTANEOUSLY, FOR DIABETES TREATMENT AND BEGINNING ON AN UNSPECIFIED DATE. ON (B)(6) 2016, UNKNOWN TIME AFTER STARTED INSULIN LISPRO 25%LISPRO+75%NPL, THE PATIENTS DIABETES WAS 380 (UNKNOWN UNITS AND REFERENCE RANGE), SO HE APPLIED THE INSULIN; HOWEVER WHEN HE MEASURED THE GLYCEMIA HE NOTED IT WAS 595 AND BECAUSE OF THIS HE WAS TAKEN TO THE EMERGENCY CARE UNIT (UPA). IN THE EMERGENCY CARE UNIT HE RECEIVED INSULIN REGULAR TO NORMALIZE THE BLOOD GLUCOSE AND THE OUTCOME WAS NOT PROVIDED. THE GLYCEMIA OF 595 WAS CONSIDERED AS SERIOUS BY THE COMPANY DUE TO MEDICALLY SIGNIFICANT REASONS. IT WAS REPORTED THE PATIENTS FATHER WENT TO A LECTURE IN WHICH THE COMPANY'S GUIDING INSTRUCTED TO STORE THE IN-USE CARTRIDGE OF INSULIN AT ROOM TEMPERATURE, BUT NOWADAYS HE WAS LIVING IN A WARM WEATHER CITY AND THE TREATING PHYSICIAN INSTRUCTED HIM TO STORE IN THE REFRIGERATOR. THE GLYCEMIC EVENT OCCURRED DURING THE USE OF THE CARTRIDGE OF INSULIN LISPRO 25%LISPRO+75%NPL (LOT C382212C), WHICH WERE STORED ACCORDING TO COMPANY'S GUIDING INSTRUCTIONS. IN ADDITION, IT WAS REPORTED THE PATIENT STORED THE PEN AT ROOM TEMPERATURE, PRIMED THE PEN AND ALWAYS REUSED NEEDLES. THE INSULIN LISPRO 25%LISPRO+75%NPL WAS CONTINUED. THE PATIENT OPERATED THE DEVICE AND HE WAS TRAINED BY THE COMPANY'S GUIDING. THE PATIENT USED THIS DEVICE MODEL AND THE REPORTED DEVICE FOR UNKNOWN TIME. THERE WAS NO REPORTED COMPLAINT FOR THIS DEVICE AND IT WAS NOT RETURNED. THE CONSUMER REPORTER DID NOT PROVIDE ANY RELATEDNESS OPINION. UPDATE 06APR2016: UPON REVIEW, THIS CASE WAS OPENED TO UPDATE THE MEDWATCH AND EUROPEAN AND CANADIAN REQUIRED DEVICE REPORTING ELEMENTS FOR REGULATORY REPORTING. UPDATE 26APR2016: ADDITIONAL INFORMATION RECEIVED ON 26APR2016 FROM THE GLOBAL PRODUCT COMPLAINT DATABASE ADDED THE DEVICE SPECIFIC SAFETY SUMMARY; ADDED THE DEVICE WAS NOT RETURNED; UPDATED THE MEDWATCH AND EUROPEAN AND CANADIAN REQUIRED DEVICE REPORTING ELEMENTS; AND UPDATED THE NARRATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229601 HUMAPEN LUXURA CHAMPAGNE FOR TREATMENT PURPOSES FMF ELI LILLY AND COMPANY MS9663 1305B09

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Other