BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMAPEN MEMOIR

    MDR report key: 2240964 · Received September 9, 2011

    Report

    Report Number
    1819470-2011-00113
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Report Date
    August 11, 2011
    Manufacturer
    ELI LILLY AND COMPANY
    Product Code
    NSC
    PMA / PMN Number
    K053563
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    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 PATIENT REPORTED THAT THEIR HUMAPEN MEMOIR DEVICE DISPLAYED UNITS UP TO AND INCLUDING 9, BUT AT DOSES ABOVE 9 UNITS, IT WAS DIFFICULT TO SEE THE LAST DIGIT. A DETAILED INVESTIGATION OF THE RETURNED DEVICE (BATCH 1005C02, MANUFACTURED MAY 2010) CONFIRMED MISSING SEGMENTS IN THE DOSE NUMBERS AND DETERMINED THE ROOT CAUSE TO BE A DEFICIENT BOND BETWEEN THE LCD 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 Q3 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 Q1 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)(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 TAKING AN UNSPECIFIED MEDICATION FOR AN UNSPECIFIED INDICATION. ON (B)(6) 2011, IT WAS REPORTED THAT THE PATIENT'S HUMAPEN MEMOIR INSULIN INJECTION DEVICE DOSE DISPLAY WAS NOT DISPLAYING THE WHOLE NUMBER IN THE LAST DIGIT OF THE UNITS DISPLAY. THE DISPLAY UP TO AND INCLUDING 9 UNITS WAS OKAY, BUT AFTER THAT THE LAST DIGIT WAS DIFFICULT TO SEE. THIS COMPLAINT WAS ASSOCIATED WITH PRODUCT COMPLAINT (B)(4) /LOT NUMBER 1005C02. THE HUMAPEN MEMOIR WAS RETURNED TO THE MANUFACTURER ON (B)(4) 2011. THE DEVICE OPERATOR AND THE DEVICE OPERATOR'S TRAINING STATUS WAS NOT PROVIDED. THE DEVICE DURATION OF USE WAS NOT PROVIDED.

    Description of Event or Problem · 1

    (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 TAKING AN UNSPECIFIED MEDICATION FOR AN UNSPECIFIED INDICATION. ON (B)(6) 2011, IT WAS REPORTED THAT THE PATIENT'S HUMAPEN MEMOIR INSULIN INJECTION DEVICE DOSE DISPLAY WAS NOT DISPLAYING THE WHOLE NUMBER IN THE LAST DIGIT OF THE UNITS DISPLAY. THE DISPLAY UP TO AND INCLUDING 9 UNITS WAS OKAY, BUT AFTER THAT THE LAST DIGIT WAS DIFFICULT TO SEE. THIS COMPLAINT WAS ASSOCIATED WITH PRODUCT COMPLAINT (B)(4) /LOT NUMBER 1005C02. THE HUMAPEN MEMOIR WAS RETURNED TO THE MANUFACTURER ON (B)(6) 2011. THE DEVICE OPERATOR AND THE DEVICE OPERATOR'S TRAINING STATUS WAS NOT PROVIDED. THE DEVICE DURATION OF USE WAS NOT PROVIDED. UPDATE (B)(6) 2011: ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2011 FROM THE GLOBAL PRODUCT COMPLAINT DATABASE ADDED THE DEVICE SPECIFIC SAFETY SUMMARY AND MANUFACTURED DATED; AND UPDATED THE MEDWATCH, EU/CA FIELDS, AND THE NARRATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMAPEN MEMOIR FOR TREATMENT PURPOSES NSC ELI LILLY AND COMPANY MS9660 1005C02

    Patients

    Seq Age Sex Outcome Treatment
    1