BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMAPEN LUXURA HALF-DOSE PEN

    MDR report key: 9386360 · Received November 27, 2019

    Report

    Report Number
    1819470-2019-00210
    Event Type
    Injury
    Date Received
    November 27, 2019
    Date of Event
    October 31, 2019
    Report Date
    November 27, 2019
    Manufacturer
    ELI LILLY AND COMPANY
    Product Code
    FMF
    PMA / PMN Number
    K100988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    LILLY CASE ID: (B)(4). THIS REPORT IS ASSOCIATED WITH PRODUCT COMPLIANT: THIS SOLICITED CASE, REPORTED BY A CONSUMER VIA A PATIENT SUPPORT PROGRAM (PSP), WITH ADDITIONAL INFORMATION FROM A SECOND CONSUMER VIA PSP, CONCERNED AN (B)(6)-YEAR-OLD FEMALE PATIENT OF UNKNOWN ORIGIN. MEDICAL HISTORY INCLUDED A DIABETIC COMA IN 2018, BEFORE BEING DIAGNOSED WITH DIABETES. CONCOMITANT MEDICATIONS INCLUDED INSULIN GLARGINE. THE PATIENT RECEIVED INSULIN LISPRO (RDNA ORIGIN) INJECTIONS (HUMALOG 100U/ML) CARTRIDGES VIA A REUSABLE PEN (HUMAPEN LUXURA, HALF-DOSE PEN), SUBCUTANEOUSLY, FOR THE TREATMENT OF DIABETES MELLITUS, BEGINNING ON (B)(6) 2018. SHE RECEIVED 4 IU IN THE MORNING, 4 IU AFTER LUNCH AND 3 IU AT NIGHT. IN (B)(6) 2019, EIGHT MONTHS AFTER STARTING INSULIN LISPRO TREATMENT, SHE EXPERIENCED BLOATING, STOMACHACHE AND SEVERE ABDOMINAL PAIN. DUE TO THE EVENTS OF BLOATING AND SEVERE ABDOMINAL PAIN, SHE WAS HOSPITALIZED IN THE INTENSIVE CARE UNIT FOR TWO DAYS DURING (B)(6) 2019. HOSPITALIZATION DETAILS INCLUDING SPECIFIC ADMISSION AND DISCHARGE DATES, LABORATORY EXAMINATION FINDINGS AND CORRECTIVE TREATMENT WERE NOT PROVIDED. SINCE (B)(6) 2019, SHE HAD BAD PSYCHOLOGICAL STATE. REPORTEDLY, SHE DID NOT GO TO HER SCHOOL REGULARLY. DETAILS WERE NOT PROVIDED. LATER, AROUND MID (B)(6) 2019, SHE HAD ACETONE IN URINE (AS REPORTED +4, NO REFERENCE RANGE PROVIDED). THIS EVENT WAS CONSIDERED SERIOUS DUE TO ITS MEDICAL SIGNIFICANCE BY THE COMPANY. SINCE AN UNKNOWN DATE WHILE ON INSULIN LISPRO TREATMENT, HER TWO HUMAPEN LUXURA, HALF-DOSE PEN WERE HEAVY TO PUSH DOSES, THEN THEY BEGAN TO NOT FUNCTION PROPERLY (ASSOCIATED PRODUCT COMPLAINTS (PCS) 4944606/ LOT NUMBER 1208G08). SHE RECEIVED INSULIN LISPRO DOSES UNTIL THE PENS GOT STUCK, AROUND (B)(6) 2019, SHE DID NOT MISS DOSES. ON (B)(6) 2019, SHE STARTED TO EXPERIENCE HIGH BLOOD GLUCOSE LEVEL, HER BLOOD GLUCOSE REACHED 600 MG/DL; THIS EVENT WAS CONSIDERED SERIOUS BY THE COMPANY DUE TO ITS MEDICAL SIGNIFICANCE. LATER HER BLOOD GLUCOSE DECREASED TO 300 MG/DL THEN REACHED 455MG/DL AND THEN ON AN UNSPECIFIED DATE WAS AT 41MG/DL (REFERENCE VALUES NOT PROVIDED FOR ALL THE ABOVE). THE OUTCOME OF THE EVENT OF BLOOD GLUCOSE WAS 41MG/ML WAS NOT PROVIDED. SHE HAD NOT RECOVERED FROM ANY OF THE REMAINING EVENTS. CORRECTIVE TREATMENT WAS NOT REPORTED. INSULIN LISPRO TREATMENT WAS CONTINUED. THE USER OF THE HUMAPEN LUXURA, HALF-DOSE PENS AND THE TRAINING STATUS WERE NOT PROVIDED. THE GENERAL HUMAPEN LUXURA, HALF-DOSE PEN AND SUSPECT HUMAPEN LUXURA, HALF-DOSE PENS DURATION OF USE WAS OF TWELVE MONTHS. THE HUMAPEN LUXURA, HALF-DOSE PENS WERE NO LONGER IN USE AND THEIR RETURN STATUS WAS UNKNOWN. THE FIRST REPORTING CONSUMER RELATED THE EVENTS OF ABDOMINAL PAIN, BLOATING, ACETONE IN URINE AND HIGH BLOOD GLUCOSE TO INSULIN LISPRO THERAPY. THE FIRST REPORTING CONSUMER RELATED THE ACETONE IN URINE AND THE BLOOD GLUCOSE INCREASED TO THE HUMAPEN LUXURA, HALF-DOSE PENS, AND DID NOT RELATE THE REMAINING EVENTS TO THE DEVICES. THE SECOND REPORTING CONSUMER RELATED THE EVENT OF HIGH BLOOD SUGAR TO THE TREATMENT WITH INSULIN LISPRO, DID NOT KNOW IF THE BAD PSYCHOLOGICAL STATE WAS RELATED TO INSULIN LISPRO AND DID NOT RELATE THE EVENTS OF ACETONE IN URINE, BLOATING AND STOMACHACHE TO INSULIN LISPRO TREATMENT. THE SECOND REPORTING CONSUMER RELATED THE EVENTS OF ACETONE IN URINE AND HIGH BLOOD GLUCOSE TO THE HUMAPEN LUXURA HD PEN AND DID NOT RELATED THE EVENTS OF BAD PSYCHOLOGICAL STATE, BLOATING AND STOMACHACHE TO THE HUMAPEN LUXURA HD PEN. NO OTHER OPINION OF CAUSALITY WAS PROVIDED. UPDATE 11-NOV-2019: ADDITIONAL INFORMATION RECEIVED ON 04-NOV-2019 FROM A SECOND CONSUMER VIA A PSP. ADDED A NEW REPORTING CONSUMER, LABORATORY DATA, AND THE NON-SERIOUS EVENTS OF ABDOMINAL PAIN UPPER, MENTAL DISORDER AND BLOOD GLUCOSE DECREASED. DESCRIPTION AS REPORTED OF THE SERIOUS EVENT OF BLOOD GLUCOSE INCREASED WAS UPDATED WITH THE FOLLOWING DESCRIPTION: THEN REACHED 455MG/DL. NARRATIVE AND FIELDS WERE UPDATED ACCORDINGLY. EDIT 18NOV2019: UPDATED MEDWATCH FIELDS FOR EXPEDITED DEVICE REPORTING. NO NEW INFORMATION ADDED. UPDATE 20NOV2019: (B)(4) RECEIVED, PROCESSED AND ADDED TO THE NARRATIVE. NO NEW INFORMATION ADDED. EDIT 22NOV2019: THE UNIQUE DEVICE IDENTIFIER OF (B)(4) FOR THE HUMAPEN LUXURA HALF-DOSE DEVICES WAS ADDED FOR EXPEDITED DEVICE REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1182146 HUMAPEN LUXURA HALF-DOSE PEN FOR TREATMENT PURPOSES FMF ELI LILLY AND COMPANY MS9673A 1208G08

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Other