BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMAPEN MEMOIR

    MDR report key: 2223791 · Received August 26, 2011

    Report

    Report Number
    1819470-2011-00106
    Event Type
    Malfunction
    Date Received
    August 26, 2011
    Report Date
    April 28, 2011
    Manufacturer
    ELI LILLY AND COMPANY
    Product Code
    NSC
    PMA / PMN Number
    K053563
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT INCLUDES FINAL EVALUATION FINDINGS. NO ADDITIONAL INFORMATION IS EXPECTED. EVALUATION SUMMARY: THE USER RETURNED THE ACTUAL COMPLAINT DEVICE (BATCH 0903C02, MANUFACTURED MARCH 2009) FOR INVESTIGATION. THE EVALUATION OF THE RETURNED DEVICE IDENTIFIED DOSE NUMBERS WITH MISSING SEGMENTS. A DETAILED INVESTIGATION FOUND THE ROOT CAUSE TO BE LIQUID INGRESS WITH A CONTRIBUTING FACTOR OF A CRACKED LCD CABLE. THE LIQUID INGRESS RESULTED IN RUST, RESIDUE AND CORROSION THROUGHOUT THE PEN'S ASSEMBLIES. THE LIQUID THAT CAUSED THE MALFUNCTION IS UNKNOWN. THE REPORTABLE MALFUNCTION MISSING DOSE NUMBER SEGMENTS MAY RESULT IN AN INACCURATE DOSE OF INSULIN. MALFUNCTION CONFIRMED. THE USER WOULD BE AWARE OF MISSING DOSE NUMBER SEGMENTS. IF ANY PART OF THE PEN DISPLAY IS MISSING DO NOT USE PEN. IF THE DISPLAY IS NOT WORKING CORRECTLY TO CONTACT LILLY OR YOUR HEALTHCARE PROFESSIONAL. CORRECTIVE ACTION, CRACKED LCD CABLE-A CORRECTIVE ACTION WAS IMPLEMENTED IN (B)(4) 2010 BEGINNING WITH BATCH 1007C01 IN WHICH AN ADDITIONAL ON-LINE CONTROL STATION WAS ADDED TO FURTHER IMPROVE DETECTION OF MISSING SEGMENTS. IN ADDITION, A CORRECTIVE ACTION HAS BEEN INITIATED TO REPLACE THE EXISTING MEMOIR LCD CABLE TO IMPROVE THE LCD CABLE ROBUSTNESS AND TO ENHANCE CONTROLS OF THE CABLE BONDING PROCESS TO THE LCD UNIT. DUE TO THE TIME REQUIRED TO QUALIFY THE NEW SUPPLIER OF CABLES, THESE IMPROVEMENTS ARE TARGETED FOR IMPLEMENTATION BY (B)(4) 2012, AND SUPPLY OF HUMAPEN MEMOIR HAS BEEN TEMPORARILY INTERRUPTED WHILE IMPROVEMENTS ARE BEING IMPLEMENTED. CORRECTIVE ACTION, MOISTURE/LIQUID INGRESS-A CORRECTIVE ACTION TO REDESIGN THE FLEXIBLE CIRCUIT BOARD TO IMPROVE THE PROTECTION OF ELECTRONIC COMPONENTS AGAINST MOISTURE INGRESS HAS BEEN INITIATED. DUE TO THE COMBINATION OF THIS IMPROVEMENT WITH OTHER PLANNED CORRECTIVE ACTIONS, THIS IMPROVEMENT IS TARGETED FOR IMPLEMENTATION BY (B)(4) 2012. IMPROPER USE AND STORAGE-THE TYPE OF LIQUID IS UNKNOWN. THEREFORE, THE MALFUNCTION CANNOT BE ATTRIBUTED TO IMPROPER USE OR STORAGE. THE PATIENT DID REUSE NEEDLES; HOWEVER, THIS APPEARS TO BE UNRELATED TO THE COMPLAINT.

    Additional Manufacturer Narrative · 1

    REPORTABLE MALFUNCTION/INCIDENT IDENTIFIED. INVESTIGATION IN PROGRESS. 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 REPORT A PRODUCT COMPLAINT, CONCERNED A FEMALE OF UNKNOWN AGE AND ORIGIN. MEDICAL HISTORY INCLUDED TYPE II DIABETES SINCE APPROXIMATELY 1996 OR 1999. CONCOMITANT MEDICATIONS INCLUDED METFORMIN FOR TYPE II DIABETES AND OTHER UNSPECIFIED MEDICATIONS. THE PATIENT RECEIVED HUMAN INSULIN ISOPHANE SUSPENSION 70%/ HUMAN REGULAR INSULIN 30% (HUMULIN 70/30) CARTRIDGE VIA A HUMAPEN MEMOIR, DOSING REGIMEN OF TWICE DAILY, FOR THE TREATMENT OF TYPE II DIABETES BEGINNING ON AN UNSPECIFIED DATE. ON AN UNSPECIFIED DATE, THE PATIENT EXPERIENCED HIGH BLOOD SUGARS AVERAGING ABOUT 14 MMOL/L. THE PATIENT'S PHYSICIAN SWITCHED THE PATIENT TO INSULIN LISPRO PROTAMINE SUSPENSION 75%/ INSULIN LISPRO 25% (HUMALOG MIX 75/25) CARTRIDGE VIA HUMAPEN MEMOIR, DOSING REGIMEN OF THREE TIMES DAILY FOR THE TREATMENT OF TYPE II DIABETES. AFTER SWITCHING HER BLOOD SUGARS AVERAGED ABOUT 10 MMOL/L. SHE WAS BETTER, BUT ALSO NEEDED TO MONITOR HER BLOOD SUGARS BETTER. ON AN UNSPECIFIED DATE, THE PATIENT'S MEMORY PROBLEMS HAD GOTTEN WORSE SINCE BEING ON INSULIN. SHE LIKED USING THE HUMAPEN MEMOIR BECAUSE SHE HAD TROUBLE REMEMBERING HER INJECTIONS. SHE HAD TWO HUMAPEN MEMOIRS THAT WERE NOT WORKING. THE BATTERY SYMBOL WAS APPEARING ON BOTH PENS. THIS WAS ASSOCIATED WITH PRODUCT COMPLAINT (B)(4) / LOT NUMBER 0903C02 AND (B)(4) / LOT UNKNOWN. ON EVALUATION OF THE HUMAPEN MEMOIR (PRODUCT COMPLAINT (B)(4) / LOT NUMBER 0903C02), THE DEVICE WAS FOUND TO HAVE A FAINT DISPLAY AND MISSING SEGMENTS IN THE DOSE DISPLAY. SHE HAD NOT TALKED TO HER PHYSICIAN ABOUT HER MEMORY PROBLEMS. SHE COULD REMEMBER NAMES AND FACES. THE PATIENT HAD BLURRY VISION. HER ENDOCRINOLOGIST EXAMINED HER AND COULD NOT FIND ANYTHING WRONG. SHE WAS GOING TO GO SEE AN EYE SPECIALIST. SHE WORE MAGNIFYING GLASSES BECAUSE SHE DID BEADWORK. SHE ALSO EXPERIENCED CHRONIC KNEE, NECK AND BACK PAIN. THE PATIENT HAD BEEN IN TWO CAR ACCIDENTS ON UNSPECIFIED DATES. SHE ALSO HAD ARTHRITIS AND SCIATICA. IN 2001, THE PATIENT HAD UNSPECIFIED SURGERY ON HER KNEE CAPS. SHE WAS GOING TO START MOVEMENT CLASSES. IT WAS UNKNOWN IF THE PATIENT RECOVERED FROM THE EVENTS. IT WAS UNKNOWN IF INSULIN LISPRO PROTAMINE SUSPENSION 75%/ INSULIN LISPRO 25% WAS CONTINUED. THE PATIENT WAS THE USER OF THE PEN AND TRAINED VIA A NURSE. THE DEVICE HAD BEEN IN USE FOR APPROXIMATELY ONE YEAR. NEEDLES WERE OCCASIONALLY REUSED. THE PEN WAS RETURNED ON (B)(4) 2011. UPDATE 18AUG2011: ADDITIONAL INFORMATION WAS RECEIVED ON (B)(4) 2011 FROM THE PRODUCT COMPLAINT SAFETY DATABASE. LOT NUMBER UNKNOWN WAS CORRECTED TO 0903C02. UPDATED PRODUCT TAB FOR HUMAPEN MEMOIR AND UPDATED THE NARRATIVE WITH THE CHANGE. UPDATE 24AUG2011: ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2011 FROM THE GLOBAL PRODUCT COMPLAINT DATABASE UPDATED THE MALFUNCTION FIELD TO YES/CIRM, THE IMPROPER USE AND STORAGE TO YES, THE PRELIMINARY COMMENTS, AND TRAINED USER TO YES; ADDED THE RETURN DATE FOR THE DEVICE; COMPLETED THE MEDWATCH AND EU/CA FIELDS; AND UPDATED THE NARRATIVE. UPDATE 24-AUG-2011: UPON REVIEW IT WAS DETERMINED THE FOLLOW-UP DATE (B)(4) 2011 WAS ENTERED IN ERROR. ADDED THE ACCURATE FOLLOW-UP DATE OF (B)(4) 2011. UPDATE 01-SEP-2011: ADDITIONAL INFORMATION RECEIVED (B)(4) 2011 VIA GLOBAL PRODUCT COMPLAINT DATABASE. ADDITIONAL SUSPECT DEVICE ADDED TO CORRESPOND WITH NEW COMPLAINT (B)(4). UPDATED NARRATIVE. UPDATE 03OCT2011: ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2011 FROM THE GLOBAL PRODUCT COMPLAINT DATABASE ADDED THE DEVICE SPECIFIC SAFETY SUMMARY; AND UPDATED THE MEDWATCH AND EU/CA FIELDS.

    Description of Event or Problem · 1

    (B)(4). THIS SPONTANEOUS CASE, REPORTED BY A CONSUMER WHO CONTACTED THE COMPANY TO REPORT A PRODUCT COMPLAINT, CONCERNED A FEMALE OF UNKNOWN AGE AND ORIGIN. MEDICAL HISTORY INCLUDED TYPE II DIABETES SINCE APPROXIMATELY 1996 OR 1999. CONCOMITANT MEDICATIONS INCLUDED METFORMIN FOR TYPE II DIABETES AND OTHER UNSPECIFIED MEDICATIONS. THE PATIENT RECEIVED HUMAN INSULIN ISOPHANE SUSPENSION 70%/ HUMAN REGULAR INSULIN 30% (HUMULIN 70/30) CARTRIDGE VIA A HUMAPEN MEMOIR, DOSING REGIMEN OF TWICE DAILY, FOR THE TREATMENT OF TYPE II DIABETES BEGINNING ON AN UNSPECIFIED DATE. ON AN UNSPECIFIED DATE, THE PATIENT EXPERIENCED HIGH BLOOD SUGARS AVERAGING ABOUT 14 MMOL/L. THE PATIENTS PHYSICIAN SWITCHED THE PATIENT TO INSULIN LISPRO PROTAMINE SUSPENSION 75%/ INSULIN LISPRO 25% (HUMALOG MIX 75/25) CARTRIDGE VIA HUMAPEN MEMOIR, DOSING REGIMEN OF THREE TIMES DAILY FOR THE TREATMENT OF TYPE II DIABETES. AFTER SWITCHING HER BLOOD SUGARS AVERAGED ABOUT 10 MMOL/L. SHE WAS BETTER, BUT ALSO NEEDED TO MONITOR HER BLOOD SUGARS BETTER. ON AN UNSPECIFIED DATE, THE PATIENTS MEMORY PROBLEMS HAD GOTTEN WORSE SINCE BEING ON INSULIN. SHE LIKED USING THE HUMAPEN MEMOIR BECAUSE SHE HAD TROUBLE REMEMBERING HER INJECTIONS. SHE HAD TWO HUMAPEN MEMOIRS THAT WERE NOT WORKING. THE BATTERY SYMBOL WAS APPEARING ON BOTH PENS. THIS WAS ASSOCIATED WITH PRODUCT COMPLAINT (B)(4). ON EVALUATION OF THE HUMAPEN MEMOIR ((B)(4)), THE DEVICE WAS FOUND TO HAVE A FAINT DISPLAY AND MISSING SEGMENTS IN THE DOSE DISPLAY. SHE HAD NOT TALKED TO HER PHYSICIAN ABOUT HER MEMORY PROBLEMS. SHE COULD REMEMBER NAMES AND FACES. THE PATIENT HAD BLURRY VISION. HER ENDOCRINOLOGIST EXAMINED HER AND COULD NOT FIND ANYTHING WRONG. SHE WAS GOING TO GO SEE AN EYE SPECIALIST. SHE WORE MAGNIFYING GLASSES BECAUSE SHE DID BEADWORK. SHE ALSO EXPERIENCED CHRONIC KNEE, NECK AND BACK PAIN. THE PATIENT HAD BEEN IN TWO CAR ACCIDENTS ON UNSPECIFIED DATES. SHE ALSO HAD ARTHRITIS AND SCIATICA. IN 2001, THE PATIENT HAD UNSPECIFIED SURGERY ON HER KNEE CAPS. SHE WAS GOING TO START MOVEMENT CLASSES. IT WAS UNKNOWN IF THE PATIENT RECOVERED FROM THE EVENTS. IT WAS UNKNOWN IF INSULIN LISPRO PROTAMINE SUSPENSION 75%/ INSULIN LISPRO 25% WAS CONTINUED. THE PATIENT WAS THE USER OF THE PEN AND TRAINED VIA A NURSE. THE DEVICE HAD BEEN IN USE FOR APPROXIMATELY ONE YEAR. NEEDLES WERE OCCASIONALLY REUSED. THE PEN WAS RETURNED ON (B)(4) 2011. UPDATE (B)(4) 2011: ADDITIONAL INFORMATION WAS RECEIVED ON (B)(4) 2011 FROM THE PRODUCT COMPLAINT SAFETY DATABASE. LOT NUMBER UNKNOWN WAS CORRECTED TO 0903C02. UPDATED PRODUCT TAB FOR HUMAPEN MEMOIR AND UPDATED THE NARRATIVE WITH THE CHANGE. UPDATE (B)(4)-2011: UPON REVIEW IT WAS DETERMINED THE FOLLOW-UP DATE (B)(4)-2011 WAS ENTERED IN ERROR. ADDED THE ACCURATE FOLLOW-UP DATE OF (B)(4)-2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMAPEN MEMOIR FOR TREATMENT PURPOSES NSC ELI LILLY AND COMPANY MS9660 0903C02

    Patients

    Seq Age Sex Outcome Treatment
    1 HUMALOG MIX 75/25| HUMULIN MIX 70/30| METFORMIN