BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMAPEN MEMOIR

    MDR report key: 1923364 · Received December 13, 2010

    Report

    Report Number
    1819470-2010-00100
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Report Date
    December 3, 2010
    Manufacturer
    ELI LILLY AND COMPANY
    Product Code
    NSC
    PMA / PMN Number
    K053563
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT INCLUDES FINAL EVALUATION FINDINGS. NO ADDITIONAL INFORMATION IS EXPECTED. EVALUATION SUMMARY: THE CALLER STATED THAT WHEN THE PATIENT DIALED HER MEMOIR DEVICE TO 60, SHE SAW ONLY A 6 IN THE DISPLAY. THE ACTUAL COMPLAINT DEVICE (LOT 0901C01, MANUFACTURED JANUARY 2009 ) WAS NOT RETURNED FOR INVESTIGATION, THEREFORE NO ROOT CAUSE OR CORRECTIVE ACTION COULD BE DETERMINED. HOWEVER THE COMPLAINT NARRATIVE SUGGESTS MISSING SEGMENTS IN THE NUMBERS OF THE DISPLAY. IF THE MISSING SEGMENTS OCCURRED IN THE DOSE NUMBERS, THIS REPORTABLE MALFUNCTION MAY RESULT IN AN INACCURATE DOSE OF INSULIN. 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, '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.' IMPROPER USE AND STORAGE - THERE IS NO EVIDENCE OF IMPROPER USE OR STORAGE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    (B)(4). THIS CASE, REPORTED BY A CONSUMER WHO CONTACTED THE COMPANY TO REPORT A PRODUCT COMPLAINT, REGARDS A FEMALE OF UNKNOWN AGE AND ORIGIN. THE PATIENT MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE PATIENT BEGAN USING INSULIN LISPRO (HUMALOG) (RDNA ORIGIN) FOR THE TREATMENT OF AN UNKNOWN INDICATION (START DATE AND DOSING REGIMEN NOT PROVIDED). THE INSULIN LISPRO WAS DELIVERED BY A HUMAPEN MEMOIR INSULIN PEN. ON (B)(6) 2010, IT WAS REPORTED THAT THE HUMAPEN MEMOIR WAS NOT DISPLAYING THE NUMBER CORRECTLY. INSTEAD OF DISPLAYING 60 UNITS, THE PATIENT WAS ONLY ABLE TO SEE A 6 (PRODUCT COMPLAINT (B)(4) / LOT 0901C01). ON THE SAME DATE IT WAS ALSO REPORTED THAT THE PATIENT HAD LARYNGITIS AND COULD NOT TALK. THE STATUS OF INSULIN LISPRO USE WAS NOT PROVIDED. THE EVENT OUTCOMES WERE NOT PROVIDED. THE DEVICE USER AND THE USER'S TRAINING STATUS WERE NOT PROVIDED. THE SUSPECT DEVICE DURATION OF USE WAS NOT PROVIDED. RETURN STATUS OF THE PEN WAS NOT PROVIDED.

    Description of Event or Problem · 1

    (B)(4). THIS CASE, REPORTED BY A CONSUMER WHO CONTACTED THE COMPANY TO REPORT A PRODUCT COMPLAINT, REGARDS A FEMALE OF UNKNOWN AGE AND ORIGIN. THE PATIENT MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE PATIENT BEGAN USING INSULIN LISPRO (HUMALOG) ((B)(4)) FOR THE TREATMENT OF AN UNKNOWN INDICATION (START DATE AND DOSING REGIMEN NOT PROVIDED). THE INSULIN LISPRO WAS DELIVERED BY A HUMAPEN MEMOIR INSULIN PEN. ON (B)(6)-2010, IT WAS REPORTED THAT THE HUMAPEN MEMOIR WAS NOT DISPLAYING THE NUMBER CORRECTLY. INSTEAD OF DISPLAYING 60 UNITS, THE PATIENT WAS ONLY ABLE TO SEE A 6 (PRODUCT COMPLAINT (B)(4)). ON THE SAME DATE IT WAS ALSO REPORTED THAT THE PATIENT HAD LARYNGITIS AND COULD NOT TALK. THE STATUS OF INSULIN LISPRO USE WAS NOT PROVIDED. THE EVENT OUTCOMES WERE NOT PROVIDED. THE DEVICE USER AND THE USER'S TRAINING STATUS WERE NOT PROVIDED. THE SUSPECT DEVICE DURATION OF USE WAS NOT PROVIDED. THE DEVICE WAS NOT RETURNED. 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 STATUS OF THE DEVICE.

    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 0901C01

    Patients

    Seq Age Sex Outcome Treatment
    1