BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMAPEN MEMOIR

    MDR report key: 2132499 · Received June 17, 2011

    Report

    Report Number
    1819470-2011-00078
    Event Type
    Injury
    Date Received
    June 17, 2011
    Report Date
    May 23, 2011
    Manufacturer
    ELI LILLY AND COMPANY
    Product Code
    NSC
    PMA / PMN Number
    K053563
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT INCLUDES FINAL EVALUATION FINDINGS. NO ADDITIONAL INFORMATION IS EXPECTED. EVALUATION SUMMARY: A PATIENT REPORTED THERE WERE FLASHING LINES IN THE DISPLAY OF HIS HUMAPEN MEMOIR DEVICE AND HIS BLOOD SUGARS WERE ELEVATED. INVESTIGATION OF THE RETURNED DEVICE (BATCH 0805C02, MANUFACTURED MAY 2008) FOUND A FLASHING BATTERY SYMBOL IN THE DISPLAY AND 244 LOW BATTERY WARNING ERRORS. THE RECURRING RESET MODE RESULTED FROM A WEAK BATTERY. MALFUNCTION CONFIRMED. THE DEVICE, HOWEVER, WAS SUCCESSFULLY RESET PER THE INSTRUCTIONS IN THE USER MANUAL AND WAS TESTED AND MET DOSE ACCURACY AND GLIDE FORCE ACCEPTANCE CRITERIA. CORRECTIVE ACTION: BEGINNING WITH BATCH 1006C01 (MANUFACTURED JUNE 2010), THE MANUFACTURER HAS CHANGED BATTERY SUPPLIERS AND IMPLEMENTED A NEW, MORE ROBUST BATTERY IN THE DEVICE. THE USER MANUAL ADDRESSES PREMATURE EXPIRATION, PERMANENT ERRORS AND RESET MODE. IMPROPER USE AND STORAGE: THERE IS NO EVIDENCE OF IMPROPER USE OR STORAGE.

    Description of Event or Problem · 1

    (B)(4). THIS SPONTANEOUS DEVICE ONLY CASE REPORTED BY A CONSUMER (VALID REPORTER INFORMATION PROVIDED BUT NOT ENTERED DUE TO LOCAL PRIVACY LAWS), WHO CONTACTED THE COMPANY TO REPORT A PRODUCT COMPLAINT, CONCERNED A MALE OF UNKNOWN AGE AND ORIGIN. MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PATIENT RECEIVED UNSPECIFIED INSULIN VIA HUMAPEN MEMOIR REUSABLE PEN, DOSING REGIMEN NOT REPORTED, FOR AN UNSPECIFIED INDICATION BEGINNING ON AN UNSPECIFIED DATE. ON AN UNSPECIFIED DATE RECENTLY, THE PATIENT DEVELOPED HIGH BLOOD SUGAR LEVELS (BLOOD SUGAR LEVELS WERE NOT REPORTED) DUE TO POOR INSULIN CONTROL, AND THE PATIENT WAS SUBSEQUENTLY ADMITTED TO THE HOSPITAL FOR ALTERATION OF HIS INSULIN REGIMEN. ADDITIONAL TREATMENT FOR THE EVENTS WAS NOT PROVIDED. IT WAS UNKNOWN IF THE PATIENT RECOVERED FROM THE EVENTS. AT THE TIME OF REPORTING, THE PATIENT REQUESTED A SPARE HUMAPEN LUXURA REUSABLE PEN AND USE OF THE HUMAPEN MEMOIR REUSABLE PEN WAS EXPECTED TO BE DISCONTINUED DUE TO FLASHING LIGHTS ON THE DISPLAY WHEN DIALING THE PEN (PRODUCT COMPLAINT (B)(4)/LOT NUMBER 0805C02). ACTION TAKEN WITH THE UNSPECIFIED INSULIN WAS UNKNOWN. THE PATIENT WAS THE OPERATOR OF THE DEVICE. IT WAS UNKNOWN IF THE PATIENT HAD BEEN TRAINED ON DEVICE USAGE. GENERAL DEVICE MODEL DURATION OF USE AND REPORTED DEVICE DURATION OF USE WERE NOT PROVIDED. UPDATE (B)(6) 2011: ADDITIONAL INFORMATION RECEIVED FROM THE PRODUCT COMPLAINT DEPARTMENT ON THE (B)(6) 2011. NO NEW ADVERSE EVENT INFORMATION WAS ADDED TO THE CASE. UPDATE (B)(6) 2011: ADDITIONAL INFORMATION RECEIVED (B)(6) 2011 VIAL GLOBAL PRODUCT COMPLAINT DATABASE. ADDED DEVICE SPECIFIC SAFETY SUMMARY. CHANGED MALFUNCTION TO YES, AND MALFUNCTION TYPE TO NOT "CIRM". ADDED DATE RETURNED TO MANUFACTURER. UPDATED EU/CA DEVICE AND MW INFO AREA FIELDS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization