BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMAPEN MEMOIR

    MDR report key: 1934481 · Received December 21, 2010

    Report

    Report Number
    1819470-2010-00101
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Report Date
    November 12, 2010
    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

    THIS IS AN INITIAL REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE FINAL EVALUATION IS COMPLETED. REPORTABLE MALFUNCTION/NEAR INCIDENT IDENTIFIED. INVESTIGATION IN PROGRESS.

    Additional Manufacturer Narrative · 1

    NEW, UPDATED AND CORRECTED INFORMATION IS REFERENCED WITHIN THE UPDATE STATEMENTS. PLEASE REFER TO UPDATE STATEMENT DATED (B)(4) 2011. THIS REPORT INCLUDES FINAL EVALUATION FINDINGS. NO ADDITIONAL INFORMATION IS EXPECTED. EVALUATION SUMMARY: THE USER REPORTED ISSUES WITH THE DISPLAY. THE USER RETURNED THE ACTUAL COMPLAINT DEVICE (LOT1003C02, MANUFACTURED MARCH 2010) FOR INVESTIGATION. A DETAILED INVESTIGATION 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 AT XXX-XXX-XXXX OR YOUR HEALTHCARE PROFESSIONAL. CORRECTIVE ACTION DEFICIENT BOND - A SPECIFIC CORRECTIVE ACTION HAS NOT YET BEEN IMPLEMENTED. HOWEVER, AN INVESTIGATION HAS BEEN INITIATED TO EVALUATE DIFFERENT OPTIONS TO REDUCE THE OCCURRENCE OF DEFICIENT BONDS. 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 INVOLVE AN ADVERSE EVENT, REPORTED BY A PHARMACY WHO CONTACTED THE COMPANY TO REPORT A PRODUCT COMPLAINT, REGARDS A PATIENT OF UNSPECIFIED GENDER, AGE, AND ORIGIN. THE PATIENT WAS TAKING AN UNKNOWN MEDICATION FOR AN UNKNOWN INDICATION. ON (B)(6) 2010, IT WAS REPORTED THAT THE PATIENT'S HUMAPEN MEMOIR DISPLAY SWITCHES OFF. THE HUMAPEN MEMOIR IS ASSOCIATED WITH PRODUCT COMPLAINT (B)(4)/ LOT 1003C02. THE DEVICE WAS RETURNED ON (B)(6) 2010, AND FOUND TO HAVE MISSING SEGMENTS IN THE DISPLAY. THE USER AND THE USER'S TRAINING STATUS WERE NOT PROVIDED. THE DURATION OF USE WAS NOT PROVIDED. THE PEN WAS RETURNED ON (B)(6) 2010.

    Description of Event or Problem · 1

    (B)(4). THIS DEVICE CASE, WHICH DOES NOT INVOLVE AN ADVERSE EVENT, REPORTED BY A PHARMACY WHO CONTACTED THE COMPANY TO REPORT A PRODUCT COMPLAINT, REGARDS A PATIENT OF UNSPECIFIED GENDER, AGE, AND ORIGIN. THE PATIENT WAS TAKING AN UNKNOWN MEDICATION FOR AN UNKNOWN INDICATION. ON (B)(6) 2010, IT WAS REPORTED THAT THE PATIENT'S HUMAPEN MEMOIR DISPLAY SWITCHES OFF. THE HUMAPEN MEMOIR IS ASSOCIATED WITH PRODUCT COMPLAINT (B)(4)/ LOT 1003C02. THE DEVICE WAS RETURNED ON (B)(6) 2010, AND FOUND TO HAVE MISSING SEGMENTS IN THE DISPLAY. THE USER AND THE USER'S TRAINING STATUS WERE NOT PROVIDED. THE DURATION OF USE WAS NOT PROVIDED. THE PEN WAS RETURNED ON (B)(6) 2010. UPDATE (B)(4) 2011: ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2011, FROM THE GLOBAL PRODUCT COMPLAINT DATABASE ADDED THE DEVICE SPECIFIC SAFETY SUMMARY; AND UPDATED THE EU/CA FIELDS.

    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 1003C02

    Patients

    Seq Age Sex Outcome Treatment
    1