BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMAPEN LUXURA, UNKNOWN PEN BODY TYPE

    MDR report key: 4448884 · Received January 24, 2015

    Report

    Report Number
    1819470-2015-00003
    Event Type
    Injury
    Date Received
    January 24, 2015
    Report Date
    December 31, 2014
    Manufacturer
    ELI LILLY AND COMPANY
    Product Code
    NSC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE DEVICE IS NOT BEING RETURNED, EVALUATION FOR A MALFUNCTION IS NOT POSSIBLE. THIS IS AN INITIAL REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE FINAL EVALUATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    (B)(4).. NO FURTHER FOLLOW UP IS PLANNED. EVALUATION SUMMARY A PATIENT REPORTED HER HUMAPEN LUXURA DEVICE "LEAKED INSULIN FROM THE NEEDLE HEAD" AFTER FINISHING THE INJECTION. SHE EXPERIENCED INCREASED BLOOD GLUCOSE. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR INVESTIGATION (BATCH UNKNOWN). THEREFORE, IT COULD NOT BE EVALUATED TO CONFIRM THE COMPLAINT OR PRESENCE OF A MALFUNCTION. MALFUNCTION UNKNOWN. THERE IS NO EVIDENCE OF IMPROPER USE OR STORAGE.

    Description of Event or Problem · 1

    LILLY CASE ID: (B)(4). THIS SOLICITED CASE, REPORTED BY A CONSUMER VIA A PATIENT SUPPORT PROGRAM, CONCERNS A (B)(6) FEMALE PATIENT BORN IN (B)(6) 1953. NO RELEVANT MEDICAL HISTORY AND NO CHANGES IN DIET, EXERCISE OR MEDICATIONS. CONCOMITANT MEDICATIONS INCLUDED INSULIN GLARGINE, ACARBOSE, AND METFORMIN. THE PATIENT RECEIVED INSULIN LISPRO (HUMALOG) 10 EACH MORNING, 8 AT NOON, AND 8 IN THE EVENING (NO UNITS PROVIDED) VIA A HUMAPEN LUXURA DEVICE FOR THE TREATMENT OF DIABETES MELLITUS BEGINNING ON (B)(6) 2009. ON (B)(6) 2014, APPROXIMATELY 5 YEARS AFTER INITIATION, THE PATIENTS BLOOD GLUCOSE WAS NOT GOOD. THE PATIENTS FASTING BLOOD GLUCOSE WAS 17.0 MOL/L AND POSTPRANDIAL BLOOD GLUCOSE WAS 18.3 MOL/L AND THE PATIENT WAS HOSPITALIZED. DURING HOSPITALIZATION, USE OF THE HUMAPEN LUXURA WAS STOPPED AS THE PEN ALWAYS LEAKED INSULIN FROM THE NEEDLE HEAD AFTER THE PATIENT FINISHED THE INJECTION (PRODUCT COMPLAINT 3221463/LOT UNKNOWN). THE SYRINGE NEEDLE WAS DISPOSABLE AND THE NEEDLE WOULD REMAIN IN THE PATIENTS SKIN FOR 5-10 SECONDS AFTER INJECTION. THE PATIENT BEGAN USING A HUMAPEN ERGO II INSTEAD. TREATMENT RECEIVED IN THE HOSPITAL WAS AN UNSPECIFIED DOSE ADJUSTMENT OF INSULIN AND ORAL MEDICATION. DETAILS WERE UNKNOWN. THE PATIENT WAS DISCHARGED ON (B)(6) 2014. ON (B)(6) 2014, THE PATIENT EXPERIENCED FASTING BLOOD GLUCOSE OF 24.7 MOL/L. ON AN UNKNOWN DATE, CURRENT TO FOLLOW-UP REPORT ON (B)(6) 2015, THE PATIENTS FASTING BLOOD GLUCOSE WAS 20-23 AND POSTPRANDIAL WAS 20-21. ON AN UNKNOWN DATE, INSULIN LISPRO DOSE WAS INCREASED TO 10 EACH MORNING, 9 AT NOON, AND 9 IN THE EVENING (DOSE UNIT NOT PROVIDED). CURRENT AS OF THE (B)(6) 2015 REPORT, THE PATIENTS BLOOD GLUCOSE REMAINED UNSTABLE WITH FASTING BLOOD GLUCOSE OF 20 AND POSTPRANDIAL BLOOD GLUCOSE OF 7 (UNITS NOT PROVIDED). THERE WAS NO CORRECTIVE TREATMENT. THE NON-SERIOUS EVENT OF BLOOD GLUCOSE INCREASED WAS NOT RECOVERED. THE REMAINING EVENT OUTCOME WAS NOT REPORTED. INSULIN LISPRO REMAINED ONGOING. THIS REPORT INCLUDED A SUSPECT HUMAPEN LUXURA DEVICE AND A SUSPECT HUMAPEN ERGO II DEVICE. THE PATIENT WAS THE USER AND TRAINING STATUS WAS UNKNOWN. GENERAL DEVICE DURATION OF USE FOR THE HUMAPEN LUXURA WAS SINCE (B)(6) 2009; SUSPECT DEVICE DURATION OF USE NOT REPORTED. GENERAL DEVICE DURATION OF USE FOR THE HUMAPEN ERGO II DEVICE WAS SINCE THE PATIENTS HOSPITALIZATION ((B)(6) 2014); SUSPECT DEVICE DURATION OF USE NOT REPORTED. THE HUMAPEN LUXURA WAS NOT RETURNED. THERE WAS NO COMPLAINT FOR THE HUMAPEN ERGO II, SO ITS RETURN WAS NOT EXPECTED. THE REPORTING CONSUMER DID NOT CONSIDER THE EVENT RELATED TO INSULIN LISPRO TREATMENT. UPDATE 08JAN2015: UPON REVIEW ON 08JAN2015, IT WAS DETERMINED THAT THE EU/CA DEVICE FIELDS WERE NOT COMPLETED. COMPLETED EU/CA FIELDS FOR HUMAPEN LUXURA. UPDATE 09JAN2015: UPON REVIEW OF THIS CASE ON 09JAN2015, THE CASE WAS OPENED TO UPDATE THE MEDWATCH FIELDS FOR REGULATORY REPORTING. UPDATE 12JAN2015: ADDITIONAL INFORMATION WAS RECEIVED FROM THE INITIAL REPORTING CONSUMER ON 09JAN2015. ADDED CURRENT BLOOD GLUCOSE VALUES, UPDATED CAUSALITY STATEMENT FROM NOT REPORTED TO NO AND UPDATED THE NARRATIVE WITH NEGATIVE MEDICAL HISTORY. UPDATE 02FEB2015: PRODUCT COMPLAINT NUMBER (B)(4) ADDED TO CASE. NO CHANGES WERE MADE TO CASE. UPDATE 04FEB2015: ADDITIONAL INFORMATION WAS RECEIVED FROM THE INITIAL REPORTING CONSUMER ON 03FEB2015. ADDED BLOOD GLUCOSE VALUES, ADDED CONCOMITANT MEDICATION, UPDATED ACTION TAKEN WITH SUSPECT DRUG, UPDATED OUTCOME OF NON SERIOUS BLOOD GLUCOSE INCREASED EVENT TO NOT RECOVERED, AND UPDATED NARRATIVE WITH THE NEW INFORMATION INCLUDING NEW DOSING REGIMEN. UPDATE 18FEB2015: ADDITIONAL INFORMATION RECEIVED ON 17FEB2015 FROM THE GLOBAL PRODUCT COMPLAINT DATABASE ADDED THE DEVICE SPECIFIC SAFETY SUMMARY; ADDED THAT THE DEVICE WAS NOT RETURNED; UPDATED THE MEDWATCH AND EU/CA FIELDS; AND UPDATED THE NARRATIVE.

    Description of Event or Problem · 1

    (B)(4). THIS SOLICITED CASE, REPORTED BY A CONSUMER VIA A PATIENT SUPPORT PROGRAM, CONCERNS A (B)(6) FEMALE PATIENT BORN IN (B)(6). NO RELEVANT MEDICAL HISTORY AND NO CHANGES IN DIET, EXERCISE OR MEDICATIONS. CONCOMITANT MEDICATIONS INCLUDED INSULIN GLARGINE AND ACARBOSE. THE PATIENT RECEIVED INSULIN LISPRO (HUMALOG) 10 EACH MORNING, 8 AT NOON, AND 8 IN THE EVENING (NO UNITS PROVIDED) VIA A HUMAPEN LUXURA DEVICE FOR THE TREATMENT OF DIABETES MELLITUS BEGINNING ON (B)(6) 2009. ON (B)(6) 2014, APPROXIMATELY 5 YEARS AFTER INITIATION, THE PATIENTS BLOOD GLUCOSE WAS NOT GOOD. THE PATIENTS FASTING BLOOD GLUCOSE WAS 17.0 MOL/L AND POSTPRANDIAL BLOOD GLUCOSE WAS 18.3 MOL/L AND THE PATIENT WAS HOSPITALIZED. DURING HOSPITALIZATION, USE OF THE HUMAPEN LUXURA WAS STOPPED AS THE PEN ALWAYS LEAKED INSULIN FROM THE NEEDLE HEAD AFTER THE PATIENT FINISHED THE INJECTION. THE SYRINGE NEEDLE WAS DISPOSABLE AND THE NEEDLE WOULD REMAIN IN THE PATIENTS SKIN FOR 5-10 SECONDS AFTER INJECTION. THE PATIENT BEGAN USING A HUMAPEN ERGO II INSTEAD. TREATMENT RECEIVED IN THE HOSPITAL WAS AN UNSPECIFIED DOSE ADJUSTMENT OF INSULIN AND ORAL MEDICATION. DETAILS WERE UNKNOWN. THE PATIENT WAS DISCHARGED ON (B)(6) 2014. ON (B)(6) 2014, THE PATIENT EXPERIENCED FASTING BLOOD GLUCOSE OF 24.7 MOL/L. ON AN UNKNOWN DATE, CURRENT TO FOLLOW-UP REPORT ON (B)(6) 2015, THE PATIENTS FASTING BLOOD GLUCOSE WAS 20-23 AND POSTPRANDIAL WAS 20-21. THE OUTCOME OF THE EVENTS WAS NOT REPORTED. INSULIN LISPRO REMAINED ONGOING. THIS REPORT INCLUDED A SUSPECT HUMAPEN LUXURA DEVICE AND A SUSPECT HUMAPEN ERGO II DEVICE. THE PATIENT WAS THE USER AND TRAINING STATUS WAS UNKNOWN. GENERAL DEVICE DURATION OF USE FOR THE HUMAPEN LUXURA WAS SINCE (B)(6) 2009; SUSPECT DEVICE DURATION OF USE NOT REPORTED. GENERAL DEVICE DURATION OF USE FOR THE HUMAPEN ERGO II DEVICE WAS SINCE THE PATIENTS HOSPITALIZATION ((B)(6) 2014); SUSPECT DEVICE DURATION OF USE NOT REPORTED. THE HUMAPEN LUXURA WAS NOT AVAILABLE FOR RETURN. THERE WAS NO COMPLAINT FOR THE HUMAPEN ERGO II, SO ITS RETURN WAS NOT EXPECTED. THE REPORTING CONSUMER DID NOT CONSIDER THE EVENT RELATED TO INSULIN LISPRO TREATMENT. UPDATE 08JAN2015: UPON REVIEW ON (B)(6) 2015, IT WAS DETERMINED THAT THE EU/CA DEVICE FIELDS WERE NOT COMPLETED. COMPLETED EU/CA FIELDS FOR HUMAPEN LUXURA. UPDATE 09JAN2015: UPON REVIEW OF THIS CASE ON (B)(6) 2015, THE CASE WAS OPENED TO UPDATE THE MEDWATCH FIELDS FOR REGULATORY REPORTING. UPDATE 12JAN2015: ADDITIONAL INFORMATION WAS RECEIVED FROM THE INITIAL REPORTING CONSUMER ON (B)(6) 2015. ADDED CURRENT BLOOD GLUCOSE VALUES, UPDATED CAUSALITY STATEMENT FROM NOT REPORTED TO NO AND UPDATED THE NARRATIVE WITH NEGATIVE MEDICAL HISTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57141 HUMAPEN LUXURA, UNKNOWN PEN BODY TYPE FOR TREATMENT PURPOSES NSC ELI LILLY AND COMPANY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization INSULIN GLARGINE| ACARBOSE| INSULIN LISPRO