BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMAPEN UNKNOWN DEVICE

    MDR report key: 3781530 · Received April 30, 2014

    Report

    Report Number
    1819470-2014-00019
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    November 30, 2013
    Report Date
    April 4, 2014
    Manufacturer
    ELI LILLY AND COMPANY
    Product Code
    NSC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 SPONTANEOUS CASE, REPORTED BY A CONSUMER WHO CONTACTED THE COMPANY TO REQUEST A NEW INSULIN PEN, CONCERNS A (B)(6) YEARS-OLD FEMALE PATIENT OF UNKNOWN ETHNICITY. THE MEDICAL HISTORY WAS NOT PROVIDED. CONCOMITANT MEDICATION: LOSARTAN POTASSIUM, INSULIN GLARGIN AND A COMPOSITION OF CYTIDINE DISODIUM PHOSPHATE, URIDINE TRIPHOSPHATE TRISODIUM, HYDROXOCOBALAMIN ACETATE AND LIDOCAINE HYDROCHLORIDEFOR (INJECTABLE) ALL OF THEM WITH UNKNOWN INDICATION. THE PATIENT RECEIVED LISPRO INSULIN (HUMALOG) VIA REUSABLE PEN, 5IU THREE TIMES DAILY, FOR THE TREATMENT OF DECOMPENSATION OF GLUCOSE, SUBCUTANEOUSLY, STARTING DATE IN APPROXIMATELY 2010. IN (B)(6) 2013, APPROXIMATELY THREE YEARS AFTER BEGINNING LISPRO INSULIN VIA HUMAPEN UNKNOWN BODY TYPE DEVICE (CONFLICTING INFORMATION RECEIVED IN FOLLOW UP WHICH THE REPORTING CONSUMER STATED THAT PATIENT BELIEVED THAT DEVICE WAS NOT A LILLY PRODUCT), THE PATIENT EXPERIENCED DECOMPENSATION OF DIABETES AND KETOACIDOSIS WHICH WERE CONSIDERED SERIOUS DUE TO MEDICALLY SIGNIFICANT REASON, BY THE COMPANY. INFORMATION REGARDING CORRECTIVE TREATMENT AND OUTCOME OF THIS FIRST EPISODE OF DECOMPENSATION OF DIABETES AND KETOACIDOSIS WAS NOT REPORTED. ON UNDISCLOSED DATE THE PATIENT EXPERIENCED A WOUND IN THE VAGINA. DUE TO WOUND IN THE VAGINA, THE PATIENT WAS HOSPITALIZED IN (B)(6) 2014. ACCORDING TO REPORTER CONSUMER, ON UNSPECIFIED DATE, THE WOUND IN VAGINA CAUSED A GENERALIZED INFECTION AND APPROXIMATELY ON (B)(6) 2014, IT ALSO CAUSED KETOACIDOSIS DIABETIC AND A LOT OF DECOMPENSATION OF DIABETES. AT THE HOSPITAL THE PATIENT RECEIVED INJECTABLE ANTIBIOTICS AS CORRECTIVE TREATMENT FOR INFECTION BUT IT WAS NOT REPORTED IF PATIENT RECEIVED CORRECTIVE TREATMENT FOR WOUND IN THE VAGINA, KETOACIDOSIS AND DECOMPENSATION OF DIABETES. THE PATIENT WAS DISCHARGED FROM HOSPITAL AFTER EIGHT DAYS. THE PATIENT UNDERWENT BLOOD TESTS AFTER THE HOSPITALIZATION AND THE RESULTS WERE NORMAL. THE PATIENT WAS RECOVERED FROM ALL EVENTS. IT WAS REPORTED THAT THE HUMAPEN UNKNOWN BODY TYPE USED TO DELIVER LISPRO INSULIN WAS WITH A BROKEN BUTTON, THE BUTTON WAS HARD. THE PATIENT CONTINUED THE TREATMENT WITH LISPRO INSULIN. IT WAS UNKNOWN WHO OPERATED THE DEVICE AND IF WAS TRAINED. THE DEVICE MODEL AND THIS REPORTED DEVICE HAD BEEN USED FOR TWO YEARS. THE RETURN OF DEVICE WAS NOT EXPECTED. SINCE THE DEVICE IS NOT BEING RETURNED, EVALUATION FOR A MALFUNCTION IS NOT POSSIBLE. THE REPORTING CONSUMER DID NOT RELATE THE EVENTS WITH LISPRO INSULIN. HOWEVER, THE RATIONAL WAS NOT PROVIDED. UPDATE (B)(6) 2014: UPON REVIEW OF THIS CASE ON (B)(6) 2014, THE CASE WAS OPENED TO UPDATE THE MEDWATCH FIELDS FOR REGULATORY REPORTING. UPDATE (B)(6) 2014. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2014 FROM INITIAL REPORTING CONSUMER, ADDED CONFLICTING INFORMATION REGARDING THE DEVICE IN NARRATIVE. UPDATE (B)(6) 2014. FOLLOW UP RECEIVED ON (B)(6) 2014 FROM INITIAL REPORTING CONSUMER. ADDED SERIOUS EVENTS OF KETOACIDOSIS, WOUND IN THE VAGINA AND GENERALIZED INFECTION. UPGRADED THE EVENT OF DECOMPENSATION OF DIABETES TO SERIOUS AND THE START DATE AND OUTCOME WERE UPDATED. THE DOSAGE OF LISPRO INSULIN WAS UPDATED, ADDED LABORATORY TEST AND THE OPINION OF RELATEDNESS WAS CHANGED FROM NOT PROVIDED TO NOT RELATE. ALL CORRESPONDENT FIELDS WERE UPDATED. EDIT (B)(6) 2014. UPON INTERNAL REVIEW TO REGULATORY SUBMISSION, THE CONFLICTING INFORMATION THAT WAS NOT ADVERSE EVENT DUE TO ISSUE OF DEVICE WAS REMOVED OF NARRATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259669 HUMAPEN UNKNOWN DEVICE FOR TREATMENT PURPOSES NSC ELI LILLY AND COMPANY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Hospitalization| O CYTIDINE DISODIUM PHOSPHATE| HYDROXOCOBALAMIN ACETATE| LOSARTAN POTASSIUM| URIDINE TRIPHOSPHATE TRISODIUM| HUMALOG LISPRO| INSULIN GLARGINE| LIDOCAINE HYDROCHLORIDE