BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMAPEN MEMOIR

    MDR report key: 2082506 · Received May 10, 2011

    Report

    Report Number
    1819470-2011-00068
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Report Date
    April 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
    PHARMACIST

    Narratives

    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.

    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 A PATIENT REPORTED THE DISPLAY OF THEIR HUMAPEN MEMOIR DEVICE WAS DEFECTIVE. INVESTIGATION OF THE RETURNED DEVICE (BATCH 1006C01, MANUFACTURED JUNE 2010) FOUND MISSING SEGMENTS IN THE DOSE NUMBERS IN THE DISPLAY. A DETAILED INVESTIGATION FOUND THE CAUSE FOR THE MISSING SEGMENTS WAS AN INTERMITTENT ELECTRICAL CONNECTION UNDER 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 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 - THIS IS THE (B)(4) OCCURRENCE OF THIS PARTICULAR FAILURE MODE. AN INVESTIGATION HAS BEEN INITIATED TO IDENTIFY A SPECIFIC ROOT CAUSE FOR THIS FAILURE MODE. 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 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 THE PATIENT'S HUMAPEN MEMOIR PEN DISPLAY WAS DEFECTIVE. THE PEN WAS RETURNED TO THE MANUFACTURER (B)(4) 2011, AND UPON EXAMINATION MISSING DOSE NUMBER SEGMENTS WERE NOTED. (B)(4). THE USER AND THE USER'S TRAINING STATUS WAS NOT PROVIDED. THE DURATION OF USE WAS NOT PROVIDED. UPDATE (B)(4) 2011: ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2011 FROM THE GLOBAL PRODUCT COMPLAINT DATABASE ADDED THE DEVICE SPECIFIC SAFETY SUMMARY; UPDATED THE MANUFACTURED ON DATE FOR THE HUMAPEN MEMOIR; UPDATED THE MEDWATCH AND EU/CA FIELDS; AND UPDATED THE NARRATIVE.

    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 THE PATIENT'S HUMAPEN MEMOIR PEN DISPLAY WAS DEFECTIVE. THE PEN WAS RETURNED TO THE MANUFACTURER (B)(4) 2011, AND UPON EXAMINATION MISSING DOSE NUMBER SEGMENTS WERE NOTED. THIS HUMAPEN MEMOIR WAS ASSOCIATED WITH PRODUCT COMPLAINT (B)(4)/ LOT 1006C01. THE USER AND THE USER'S TRAINING STATUS WAS NOT PROVIDED. THE DURATION OF USE WAS NOT PROVIDED.

    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