BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMAPEN MEMOIR

    MDR report key: 2121487 · Received June 13, 2011

    Report

    Report Number
    1819470-2011-00075
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Report Date
    May 18, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT SUGGESTIVE OF REPORTABLE MALFUNCTION/INCIDENT. WILL INVESTIGATE FURTHER. THIS IS AN INITIAL REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE FINAL EVALUATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THIS REPORT INCLUDES FINAL EVALUATION FINDINGS. NO ADDITIONAL INFORMATION IS EXPECTED. EVALUATION SUMMARY: A PATIENT REPORTED THAT THEIR HUMAPEN MEMOIR DEVICE DISPLAY IS NOT SHOWING THE COMPLETE DIGITS. INVESTIGATION OF THE RETURNED DEVICE (BATCH 1003C02, MANUFACTURED MARCH 2010) DETERMINED THE ROOT CAUSE IS A DEFICIENT BOND BETWEEN THE CABLE AND THE LCD GLASS. 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 THAT 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 OR YOUR HEALTHCARE PROFESSIONAL. CORRECTIVE ACTION DEFICIENT BOND: 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 ENHANCE CONTROLS OF THE CABLE BONDING PROCESS TO THE LCD UNIT AND TO REPLACE THE EXISTING MEMOIR LCD CABLE TO IMPROVE THE LCD CABLE ROBUSTNESS. 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 UNTIL THESE IMPROVEMENTS HAVE BEEN IMPLEMENTED. IMPROPER USE AND STORAGE - THERE IS NO EVIDENCE OF IMPROPER USE OR STORAGE.

    Description of Event or Problem · 1

    (B)(6). THIS DEVICE CASE, WHICH DOES NOT INCLUDE AN ADVERSE EVENT, REPORTED BY A CONSUMER WHO CONTACTED THE COMPANY TO REPORT A PRODUCT COMPLAINT, REGARDS A PATIENT OF UNSPECIFIED GENDER, AGE, AND ORIGIN. THE PATIENT WAS USING AN UNSPECIFIED MEDICATION FOR THE TREATMENT OF AN UNSPECIFIED INDICATION. ON (B)(6) 2011, IT WAS REPORTED THAT THE PATIENT'S HUMAPEN MEMOIR INSULIN DELIVERY DEVICE WAS NOT SHOWING COMPLETE DIGITS IN THE DISPLAY. THE HUMAPEN MEMOIR WAS ASSOCIATED WITH PRODUCT (B)(4) / LOT NUMBER 1003C02. THE USER AND THE USER'S TRAINING STATUS WERE NOT PROVIDED. THE DURATION OF USE WAS NOT PROVIDED. THE DEVICE WAS RETURNED TO THE MANUFACTURER (B)(6) 2011.

    Description of Event or Problem · 1

    LILLY CASE ID: (B)(4). THIS DEVICE CASE, WHICH DOES NOT INCLUDE AN ADVERSE EVENT, REPORTED BY A CONSUMER WHO CONTACTED THE COMPANY TO REPORT A PRODUCT COMPLAINT, REGARDS A PATIENT OF UNSPECIFIED GENDER, AGE, AND ORIGIN. THE PATIENT WAS USING AN UNSPECIFIED MEDICATION FOR THE TREATMENT OF AN UNSPECIFIED INDICATION. ON (B)(6) 2011, IT WAS REPORTED THAT THE PATIENT'S HUMAPEN MEMOIR INSULIN DELIVERY DEVICE WAS NOT SHOWING COMPLETE DIGITS IN THE DISPLAY. THE RETURNED DEVICE WAS FOUND TO HAVE MISSING SEGMENTS IN THE DOSE DISPLAY. THE HUMAPEN MEMOIR WAS ASSOCIATED WITH PRODUCT COMPLAINT (B)(4)/ LOT NUMBER 1003C02. THE USER AND THE USER'S TRAINING STATUS WERE NOT PROVIDED. THE DURATION OF USE WAS NOT PROVIDED. THE DEVICE WAS RETURNED TO THE MANUFACTURER (B)(4) 2011. UPDATE 30-JUN-2011: ADDITIONAL INFORMATION RECEIVED (B)(4) 2011 VIA GLOBAL PRODUCT COMPLAINT DATABASE. ADDED DEVICE SPECIFIC SAFETY SUMMARY. UPDATED DEVICE EU/CA AND MEDWATCH INFO FIELDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMAPEN MEMOIR FOR TREATMENT PURPOSES NSC ELI LILLY AND COMPANY MS9660 1003C02

    Patients

    Seq Age Sex Outcome Treatment
    1