BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMAPEN MEMOIR

    MDR report key: 2133182 · Received June 20, 2011

    Report

    Report Number
    1819470-2011-00079
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Report Date
    May 27, 2011
    Manufacturer
    ELI LILLY AND COMPANY
    Product Code
    NSC
    PMA / PMN Number
    K053563
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    NARRATIVE FIELD - NEW, UPDATED AND CORRECTED INFORMATION IS REFERENCED WITHIN THE UPDATE STATEMENTS. PLEASE REFER TO UPDATE STATEMENT DATED (B)(6) 2011. THIS REPORT INCLUDES FINAL EVALUATION FINDINGS. NO ADDITIONAL INFORMATION IS EXPECTED. EVALUATION SUMMARY A USER REPORTED THAT MEASURING IS NOT POSSIBLE WITH THEIR HUMAPEN MEMOIR DEVICE. INVESTIGATION OF THE RETURNED THE DEVICE (BATCH 1006C01, MANUFACTURED JUNE 2010) FOUND MISSING DOSE SEGMENTS IN THE DISPLAY DUE TO AN OPEN SOLDER JOINT IN THE MICROPROCESSOR. THE REPORTABLE MALFUNCTION MISSING DOSE NUMBER SEGMENTS MAY RESULT IN AN INACCURATE DOSE OF INSULIN. MALFUNCTION CONFIRMED. THE USER WOULD TYPICALLY BE AWARE OF MISSING DOSE NUMBER SEGMENTS. WHEN THE PEN IS POWERED ON, ALL SEGMENTS OF THE DISPLAY ARE ILLUMINATED TO CONFIRM PROPER FUNCTION. THE USER MANUAL INSTRUCTS, IF ANY PART OF THE PEN DISPLAY IS MISSING DO NOT USE PEN. IT FURTHER INSTRUCTS THAT IF THE DISPLAY IS NOT WORKING CORRECTLY TO CONTACT LILLY AT XXX-XXX-XXXX OR YOUR HEALTHCARE PROFESSIONAL. CORRECTIVE ACTION - THIS IS THE FOURTH OCCURRENCE OF THIS PARTICULAR FAILURE MODE. AN INVESTIGATION INTO THE ROOT CAUSE IS ONGOING AND CORRECTIVE ACTIONS WILL BE DETERMINED ONCE COMPLETED. IMPROPER USE AND STORAGE - THERE IS NO EVIDENCE OF IMPROPER USE OR STORAGE.

    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

    (B)(4). THIS DEVICE CASE, WHICH DOES NOT INCLUDE AN ADVERSE EVENT, REPORTED BY A PHARMACIST WHO CONTACTED THE COMPANY TO REPORT A PRODUCT COMPLAINT, REGARDS A PATIENT OF UNSPECIFIED GENDER, AGE, AND ORIGIN. THE PATIENT WAS TAKING AN UNSPECIFIED MEDICATION FOR THE TREATMENT OF AN UNSPECIFIED INDICATION. ON (B)(6) 2011, IT WAS REPORTED THAT IT WAS IMPOSSIBLE TO MEASURE WITH THE PATIENT'S HUMAPEN MEMOIR INSULIN DELIVERY PEN. THE PEN WAS RETURNED TO THE MANUFACTURER (B)(6) 2011, AND EXAMINATION REVEALED MISSING DIGITS IN THE DOSE NUMBERS. THIS HUMAPEN MEMOIR WAS ASSOCIATED WITH PRODUCT COMPLAINT (B)(4) / (B)(4). THE USER AND THE USER'S TRAINING STATUS WERE NOT PROVIDED. THE SUSPECT DEVICE DURATION OF USE WAS NOT REPORTED. UPDATE (B)(6) 2011: ADDITIONAL INFORMATION RECEIVED ON (B)(6) 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)(6). THIS DEVICE CASE, WHICH DOES NOT INCLUDE AN ADVERSE EVENT, REPORTED BY A PHARMACIST WHO CONTACTED THE COMPANY TO REPORT A PRODUCT COMPLAINT, REGARDS A PATIENT OF UNSPECIFIED GENDER, AGE, AND ORIGIN. THE PATIENT WAS TAKING AN UNSPECIFIED MEDICATION FOR THE TREATMENT OF AN UNSPECIFIED INDICATION. ON (B)(6) 2011, IT WAS REPORTED THAT IT WAS IMPOSSIBLE TO MEASURE WITH THE PATIENT'S HUMAPEN MEMOIR INSULIN DELIVERY PEN. THE PEN WAS RETURNED TO THE MANUFACTURER (B)(6) 2011, AND EXAMINATION REVEALED MISSING DIGITS IN THE DOSE NUMBERS. THIS HUMAPEN MEMOIR WAS ASSOCIATED WITH PRODUCT (B)(4). THE USER AND THE USER'S TRAINING STATUS WERE NOT PROVIDED. THE SUSPECT DEVICE DURATION OF USE WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMAPEN MEMOIR FOR TREATMENT PURPOSES NSC ELI LILLY AND COMPANY MS9660 1006C01

    Patients

    Seq Age Sex Outcome Treatment
    1