BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMAPEN MEMOIR

    MDR report key: 1649771 · Received April 5, 2010

    Report

    Report Number
    1819470-2010-00016
    Event Type
    Malfunction
    Date Received
    April 5, 2010
    Report Date
    March 9, 2010
    Manufacturer
    ELI LILLY AND COMPANY
    Product Code
    NSC
    PMA / PMN Number
    K053563
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTABLE MALFUNCTION/NEAR INCIDENT IDENTIFIED. INVESTIGATION IN PROGRESS. THIS REPORT INCLUDES FINAL EVALUATION FINDINGS. NO ADDITIONAL INFORMATION IS EXPECTED. EVALUATION SUMMARY: A CUSTOMER RETURNED THEIR MEMOIR PEN TO THE MANUFACTURER BECAUSE THE SCREEN DISPLAY FLASHED ALL THE TIME. THE PEN BATCH 0805C02 WAS MANUFACTURED IN MAY 2008. INITIAL INVESTIGATION DETERMINED THE POWER BUTTON DID NOT WORK AND FOUND MISSING SEGMENTS IN THE DOSE DIGITS. A GLOSSY SUBSTANCE WAS OBSERVED ON THE PEN'S THREADED FRONT HOUSING AND A JELL-LIKE SUBSTANCE IN THE CREVICES. INTERNAL INSPECTION OBSERVED LIQUID INGRESS AND CORROSION IN SEVERAL AREAS. THE POWER BUTTON AIR HOLE VIA (HOLE THROUGH CIRCUIT BOARD TO ALLOW ELECTRICAL FLOW) WAS CORRODED WHICH INHIBITED POWER BUTTON OPERATION. THE LIQUID INGRESS CORRODED COPPER VIAS IN THE SIGNAL LINES TO THE LCD WHICH RESULTED IN THE MISSING SEGMENT MALFUNCTION. MISSING DOSE SEGMENTS MAY RESULT IN RECEIVING AN INCORRECT DOSE OF INSULIN. MALFUNCTION CONFIRMED. CORRECTIVE ACTION, LIQUID INGRESS: NO CORRECTIVE ACTION IS PLANNED. THE USER MANUAL STATES IN THE CARE, STORAGE, AND DISPOSAL SECTION TO KEEP THE PEN AND CASE AWAY FROM WATER, MOISTURE, OR WET SURFACES AS THE PEN AND CASE ARE NOT WATERTIGHT. USERS ARE TYPICALLY AWARE OF MISSING DOSE NUMBER SEGMENTS. THE DIRECTION FOR USE PROHIBITS CONTINUED USE. IMPROPER USE AND STORAGE. THERE IS EVIDENCE OF IMPROPER USE OR STORAGE. THE SOURCE OF THE LIQUID CONTAMINATION COULD NOT BE DETERMINED. IT DID NOT APPEAR TO BE INSULIN THEREFORE, IMPROPER USE OR STORAGE WAS CONCLUDED.

    Description of Event or Problem · 1

    (B)(4). THIS DEVICE CASE, WHICH DOES NOT INVOLVE AN ADVERSE EVENT, REPORTED BY A CONSUMER, WHO CONTACTED THE COMPANY WITH A PRODUCT COMPLAINT, CONCERNS A MALE OF UNKNOWN AGE OR ORIGIN. THE PATIENT WAS TAKING AN UNSPECIFIED MEDICATION FOR TREATMENT OF AN UNKNOWN INDICATION. ON (B)(6) 2010, THE HUMAPEN MEMOIR WAS REPORTED TO HAVE A BROKEN COLLAR. ON (B)(6) 2010, THE HUMAPEN MEMOIR WAS REPORTED TO HAVE FLASHES APPEARING ON THE DISPLAY. THIS HUMAPEN MEMOIR IS ASSOCIATED WITH PC 1213849. ON (B)(6) 2010, THE HUMAPEN MEMOIR WAS RETURNED. ON (B)(6) 2010, THE HUMAPEN MEMOIR WAS FOUND TO HAVE MISSING SEGMENTS IN THE ONE'S SPOT OF THE DOSE NUMBERS AND NO NUMBER IN THE 10'S SPOT OF THE DOSE NUMBERS IN THE DISPLAY. THE PATIENT OPERATED THE DEVICE. IT WAS UNKNOWN IF THE PATIENT WAS TRAINED. THE LENGTH OF USE FOR THE DEVICE MODEL AND THE REPORTED DEVICE WERE NOT PROVIDED. IT WAS UNKNOWN IF THE PATIENT CONTINUED TO USE THE HUMAPEN MEMOIR DEVICE MODEL. REFER TO RESULTS/CONCLUSION SECTION. UPDATE (B)(6) 2010: ADDITIONAL INFORMATION RECEIVED (B)(6) 2010; ADDED LSS SUMMARY TO QC INFO TAB; UPDATED FINAL FIELDS, FURTHER INVESTIGATION FIELD AND DELETED EXPECTED FOLLOW UP DATE ON EU/CA DEVICE BUTTON; UPDATED PSUR COMMENTS AND ADDED REFER TO RESULTS/CONCLUSIONS SECTION TO NARRATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMAPEN MEMOIR PEN INJECTOR FOR TREATMENT PURPOSES NSC ELI LILLY AND COMPANY MS9660 0805C02

    Patients

    Seq Age Sex Outcome Treatment
    1