BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMAPEN ERGO, BURGUNDY CLEAR

    MDR report key: 4952911 · Received July 30, 2015

    Report

    Report Number
    1819470-2015-00084
    Event Type
    Malfunction
    Date Received
    July 30, 2015
    Report Date
    July 16, 2015
    Manufacturer
    ELI LILLY AND COMPANY
    Product Code
    FMF
    PMA / PMN Number
    K982842
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER FOLLOW UP IS PLANNED. EVALUATION SUMMARY: A FEMALE PATIENT REPORTED THAT HER HUMAPEN ERGO DEVICE WAS LEAKING AFTER REMOVAL OF THE NEEDLE AND AFTER INJECTION. SHE EXPERIENCED HYPOGLYCEMIA. INVESTIGATION OF THE RETURNED DEVICE (BATCH 40225, MANUFACTURED MARCH 2002) FOUND BROWN FOREIGN MATERIAL CONTAMINATION ON THE DIAL, DOSE KNOB, UNDER INJECTION BUTTON AND INSIDE FRONT HOUSING. DUE TO THE CONTAMINATION, EXCESSIVE FORCE WAS NEEDED TO DOSE THE DEVICE. MALFUNCTION CONFIRMED. THE PATIENT REPORTED USING THE DEVICE SINCE 2003 (12 YEARS). THE HUMAPEN ERGO USER MANUAL STATES THE DEVICE WAS DESIGNED TO BE USED FOR UP TO 3 YEARS AFTER FIRST USE. THERE IS EVIDENCE OF IMPROPER USE. FOREIGN MATERIAL CONTAMINATION OCCURRED WHILE IN THE FIELD (NOT RELATED TO THE MANUFACTURING PROCESS). THIS MAY BE RELATED TO THE COMPLAINT OF LEAKING. THE PATIENT USED THE DEVICE BEYOND ITS APPROVED USE LIFE. THIS MAY NOT BE RELEVANT TO THE COMPLAINT WHICH LED HYPOGLYCEMIA.

    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

    (B)(4). THIS SOLICITED CASE, REPORTED BY A CONSUMER VIA A PATIENT SUPPORT PROGRAM, CONCERNS A (B)(6) FEMALE PATIENT. MEDICAL HISTORY: LIPIDS INCREASED, HYPERTENSION, CARDIO CEREBRAL BLOOD VESSEL, AND DRUG ADVERSE REACTION HISTORY OF HYPOGLYCEMIA FOR UNKNOWN MEDICINE. THE PATIENT HAD NO FAMILY DRUG REACTION. CONCOMITANT MEDICATIONS: INSULIN GLARGINE FOR DIABETES MELLITUS, SIMVASTATIN FOR HYPERLIPEMIA, AND SEVERAL UNSPECIFIED ORAL MEDICATIONS. THE PATIENT RECEIVED HUMAN INSULIN ISOPHANE SUSPENSION 70%/ HUMAN INSULIN 30% (HUMULIN 70/30; UNKNOWN FORMULATION) VIA HUMAPEN ERGO BURGUNDY/CLEAR DEVICE, DOSE TOTAL AROUND 30 UNITS DAILY DOSED BID, FOR TREATMENT OF DIABETES MELLITUS BEGINNING ON AN UNKNOWN DATE IN 2003. ON AN UNKNOWN DATE, UNKNOWN TIME TO ONSET, THE PATIENT OFTEN EXPERIENCED HYPOGLYCEMIA AT NIGHT, BLOOD GLUCOSE VALUES NOT PROVIDED. THE PATIENT WAS HOSPITALIZED FOR TREATMENT IN (B)(6) 2014. HUMAN INSULIN ISOPHANE SUSPENSION 70%/ HUMAN INSULIN 30% WAS DISCONTINUED AND THE PATIENT WAS STARTED ON HUMAN INSULIN (HUMULIN R) AT A DOSE OF 11 UNITS IN THE MORNING, 6 UNITS AT NOON, AND 10 UNITS IN THE EVENING. THE PATIENT WAS DISCHARGED AFTER TWO WEEKS. TREATMENT PROVIDED IN HOSPITAL AND BLOOD GLUCOSE VALUES WERE NOT PROVIDED. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED WEIGHT GAIN OF 15 KG SINCE START OF HUMAN INSULIN ISOPHANE SUSPENSION 70%/ HUMAN INSULIN 30%. THE PATIENT WEIGHED 45 KG PRIOR TO THERAPY, AND WEIGHT AT TIME OF REPORT IN (B)(6) 2015 WAS (B)(6). IN (B)(6) 2015, THE HUMAPEN ERGO WAS LEAKING AFTER REMOVAL OF THE NEEDLE AND AFTER THE INJECTION (LOT NUMBER 40225/PRODUCT COMPLAINT NUMBER (B)(4)). IN (B)(6) 2015, AT TIME OF INITIAL REPORT, THE CURRENT FASTING BLOOD GLUCOSE WAS AROUND 7 AND POSTPRANDIAL BLOOD GLUCOSE WAS AROUND 10 (NO UNITS). NO ADDITIONAL INFORMATION WAS PROVIDED. THE OUTCOME OF HYPOGLYCEMIA IN THE NIGHT WAS RECOVERING, OUTCOME OF GAINED WEIGHT WAS NOT RECOVERED, AND OUTCOME OF FASTING BLOOD GLUCOSE AROUND 7 WAS UNKNOWN. HUMAN INSULIN THERAPY WAS CONTINUED. THE PATIENT WAS THE USER OF THE SUSPECT HUMAPEN ERGO I DEVICE, TRAINING STATUS WAS UNKNOWN. THE DEVICE WAS IN USE SINCE 2003. ACTION TAKEN WITH THE DEVICE WAS NOT PROVIDED. DEVICE WAS RETURNED ON 29JUL2015. THE REPORTING CONSUMER CONSIDERED THE EVENTS OF HYPOGLYCEMIA AND WEIGHT INCREASED TO BE RELATED TO HUMAN INSULIN ISOPHANE SUSPENSION 70%/ HUMAN INSULIN 30%. THE CONSUMER REPORTER DID NOT PROVIDE AN OPINION OF RELATEDNESS FOR THE EVENTS IN RELATION TO HUMAN INSULIN. UPDATE 27JUL2015: UPON REVIEW OF THIS CASE, THE CASE WAS OPENED TO UPDATE THE MEDWATCH FIELDS FOR REGULATORY REPORTING. UPDATE 29JUL2015: ADDITIONAL INFORMATION RECEIVED 27JUL2015 FROM COMPANY INTERNAL PRODUCT QUALITY COMPLAINT PERSONNEL THAT A PRODUCT COMPLAINT (B)(4) HAD BEEN ADDED TO CASE AND NARRATIVE WAS UPDATED WITH NUMBER. NO OTHER CHANGES WERE MADE TO CASE. UPDATE 10AUG2015. ADDITIONAL INFORMATION RECEIVED 31JUL2015 FROM THE GLOBAL PRODUCT COMPLAINT SYSTEM. TO THE DEVICE TAB RECODED THE DEVICE TO HUMAPEN ERGO BURGUNDY/CLEAR, ADDED THE LOT NUMBER, DATE RETURNED, UPDATED THE EU/CA FIELDS, AND THE NARRATIVE ACCORDINGLY. UPDATE 28AUG2015: ADDITIONAL INFORMATION RECEIVED ON 28AUG2015 FROM THE GLOBAL PRODUCT COMPLAINT DATABASE ADDED THE DEVICE SPECIFIC SAFETY SUMMARY AND MANUFACTURED DATE OF THE DEVICE; UPDATED THE IMPROPER USE AND STORAGE TO YES; UPDATED THE MALFUNCTION FIELD TO YES/NOT CIRM; UPDATED THE MEDWATCH AND EU/CA FIELDS; AND UPDATED THE NARRATIVE.

    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. MEDICAL HISTORY: LIPIDS INCREASED, HYPERTENSION, CARDIO CEREBRAL BLOOD VESSEL, AND DRUG ADVERSE REACTION HISTORY OF HYPOGLYCEMIA FOR UNKNOWN MEDICINE. THE PATIENT HAD NO FAMILY DRUG REACTION. CONCOMITANT MEDICATIONS: INSULIN GLARGINE FOR DIABETES MELLITUS, SIMVASTATIN FOR HYPERLIPEMIA, AND SEVERAL UNSPECIFIED ORAL MEDICATIONS. THE PATIENT RECEIVED HUMAN INSULIN ISOPHANE SUSPENSION 70%/ HUMAN INSULIN 30% (HUMULIN 70/30; UNKNOWN FORMULATION) VIA HUMAPEN ERGO I DEVICE, DOSE TOTAL AROUND 30 UNITS DAILY DOSED BID, FOR TREATMENT OF DIABETES MELLITUS BEGINNING ON AN UNKNOWN DATE IN 2003. ON AN UNKNOWN DATE, UNKNOWN TIME TO ONSET, THE PATIENT OFTEN EXPERIENCED HYPOGLYCEMIA AT NIGHT, BLOOD GLUCOSE VALUES NOT PROVIDED. THE PATIENT WAS HOSPITALIZED FOR TREATMENT IN (B)(6) 2014. HUMAN INSULIN ISOPHANE SUSPENSION 70%/ HUMAN INSULIN 30% WAS DISCONTINUED AND THE PATIENT WAS STARTED ON HUMAN INSULIN (HUMULIN R) AT A DOSE OF 11 UNITS IN THE MORNING, 6 UNITS AT NOON, AND 10 UNITS IN THE EVENING. THE PATIENT WAS DISCHARGED AFTER TWO WEEKS. TREATMENT PROVIDED IN HOSPITAL AND BLOOD GLUCOSE VALUES WERE NOT PROVIDED. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED WEIGHT GAIN OF 15 KG SINCE START OF HUMAN INSULIN ISOPHANE SUSPENSION 70%/ HUMAN INSULIN 30%. THE PATIENT WEIGHED (B)(6) PRIOR TO THERAPY, AND WEIGHT AT TIME OF REPORT IN (B)(6) 2015 WAS (B)(6). IN (B)(6) 2015, THE HUMAPEN ERGO WAS LEAKING AFTER REMOVAL OF THE NEEDLE AND AFTER THE INJECTION (LOT NUMBER UNKNOWN/PRODUCT COMPLAINT NUMBER (B)(4)). IN (B)(6) 2015, AT TIME OF INITIAL REPORT, THE CURRENT FASTING BLOOD GLUCOSE WAS AROUND 7 AND POSTPRANDIAL BLOOD GLUCOSE WAS AROUND 10 (NO UNITS). NO ADDITIONAL INFORMATION WAS PROVIDED. THE OUTCOME OF HYPOGLYCEMIA IN THE NIGHT WAS RECOVERING, OUTCOME OF GAINED WEIGHT WAS NOT RECOVERED, AND OUTCOME OF FASTING BLOOD GLUCOSE AROUND 7 WAS UNKNOWN. HUMAN INSULIN THERAPY WAS CONTINUED. THE PATIENT WAS THE USER OF THE SUSPECT HUMAPEN ERGO I DEVICE, TRAINING STATUS WAS UNKNOWN. THE DEVICE WAS IN USE SINCE 2003. ACTION TAKEN WITH THE DEVICE AND RETURN STATUS WAS NOT PROVIDED. THE REPORTING CONSUMER CONSIDERED THE EVENTS OF HYPOGLYCEMIA AND WEIGHT INCREASED TO BE RELATED TO HUMAN INSULIN ISOPHANE SUSPENSION 70%/ HUMAN INSULIN 30%. THE CONSUMER REPORTER DID NOT PROVIDE AN OPINION OF RELATEDNESS FOR THE EVENTS IN RELATION TO HUMAN INSULIN. UPDATE 27JUL2015: UPON REVIEW OF THIS CASE, THE CASE WAS OPENED TO UPDATE THE MEDWATCH FIELDS FOR REGULATORY REPORTING. UPDATE 29JUL2015: ADDITIONAL INFORMATION RECEIVED 27JUL2015 FROM COMPANY'S INTERNAL PRODUCT QUALITY COMPLAINT PERSONNEL THAT A PRODUCT COMPLAINT (B)(4) HAD BEEN ADDED TO CASE AND NARRATIVE WAS UPDATED WITH NUMBER. NO OTHER CHANGES WERE MADE TO CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497577 HUMAPEN ERGO, BURGUNDY CLEAR FOR TREATMENT PURPOSES FMF ELI LILLY AND COMPANY MS8930 40225

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization INSULIN GLARGINE