BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMAPEN MEMOIR

    MDR report key: 2183472 · Received July 29, 2011

    Report

    Report Number
    1819470-2011-00099
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Report Date
    July 8, 2011
    Manufacturer
    ELI LILLY AND COMPANY
    Product Code
    NSC
    PMA / PMN Number
    K053563
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHARMACIST

    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

    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 THE PATIENT REPORTED THEIR HUMAPEN MEMOIR DEVICE DISPLAYED AN ERROR MESSAGE IN THE SCREEN REPORTED AS E8. INVESTIGATION OF THE RETURNED DEVICE (BATCH 905C01, MANUFACTURED MAY 2009) FOUND A PERMANENT ERROR CODE F8 IN THE DISPLAY. THE PERMANENT ERROR CODE F8 INDICATES THE ELECTRICAL-SELF TEST (EST) HAS FAILED. A PERMANENT ERROR CODE F8 REMAINS IN THE DISPLAY AND NO DOSES WILL APPEAR, EVEN IF THE USER TRIES TO DIAL THEIR DOSE. THIS MALFUNCTION RENDERS THE DEVICE UNUSABLE AND MAY RESULT IN AN INACCURATE DOSE OF INSULIN ONLY IF THE USER ATTEMPTS TO DIAL THEIR DOSE BY INCORRECTLY DIALING A DOSE BY COUNTING CLICKS BECAUSE THE DEVICE REMAINS MECHANICALLY FUNCTIONAL. A REPORTABLE MALFUNCTION OF MISSING OR EXTRA SEGMENTS WAS NOT OBSERVED DURING THE INVESTIGATION. THE USER MANUAL INSTRUCTS THAT IF THE DISPLAY EXHIBITS A PERMANENT ERROR CODE DO NOT USE THE PEN; CONTACT LILLY AT XXX-XXX-XXXX OR YOUR HEALTHCARE PROFESSIONAL. 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 INSULIN LISPRO (HUMALOG) FOR AN UNKNOWN INDICATION. ON (B)(6) 2011 IT WAS REPORTED THAT THE PATIENT'S HUMAPEN MEMOIR DISPLAYED AN ERROR MESSAGE IN THE SCREEN REPORTED AS EB. THE HUMAPEN MEMOIR WAS ASSOCIATED WITH PRODUCT COMPLAINT (B)(4) / LOT 0905C01. UPON EVALUATION, THE DEVICE WAS FOUND TO HAVE A PERMANENT ERROR CODE OF F8, AND NO MISSING OR EXTRA SEGMENTS WERE SEEN. THE USER AND THE USER'S TRAINING STATUS WERE NOT PROVIDED. THE DURATION OF USE WAS NOT PROVIDED. THE DEVICE WAS RETURNED ON (B)(6) 2011. UPDATE (B)(6) 2011: ADDITIONAL INFORMATION RECEIVED (B)(6) 2011 VIA GLOBAL PRODUCT COMPLAINT DATABASE. UPDATED LOT NUMBER. UPDATE (B)(6) 2011: ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2011 FROM THE GLOBAL PRODUCT COMPLAINT DATABASE ADDED THE DEVICE SPECIFIC SAFETY SUMMARY; UPDATED THE MALFUNCTION FIELD TO YES/NOT CIRM; ADDED THE RETURNED DATED FOR THE DEVICE; AND UPDATED THE NARRATIVE.

    Description of Event or Problem · 1

    (B)(6). 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 INSULIN LISPRO (HUMALOG) FOR AN UNKNOWN INDICATION. ON (B)(6) 2011, IT WAS REPORTED THAT THE PATIENT'S HUMAPEN MEMOIR DISPLAYED AN ERROR MESSAGE IN THE SCREEN REPORTED AS EB. THE HUMAPEN MEMOIR WAS ASSOCIATED WITH PRODUCT (B)(4) / LOT 0905C01. THE USER AND THE USER'S TRAINING STATUS WERE NOT PROVIDED. THE DURATION OF USE WAS NOT PROVIDED. RETURN STATUS OF THE PEN WAS NOT PROVIDED. UPDATE (B)(6) 2011: ADDITIONAL INFORMATION RECEIVED (B)(6) 2011 VIA (B)(6) DATABASE. UPDATED LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMAPEN MEMOIR FOR TREATMENT PURPOSES NSC ELI LILLY AND COMPANY MS9660 0905C01

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR HUMALOG