BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMAPEN MEMOIR

    MDR report key: 1203753 · Received October 9, 2008

    Report

    Report Number
    1819470-2008-00054
    Event Type
    Malfunction
    Date Received
    October 9, 2008
    Report Date
    September 12, 2008
    Manufacturer
    ELI LILLY AND CO.
    Product Code
    FMF
    PMA / PMN Number
    K053563
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THIS DEVICE CASE, WHICH DOES NOT INVOLVE AN ADVERSE EVENT, REPORTED BY THE CONSUMER WHO CONTACTED THE COMPANY WITH A PRODUCT COMPLAINT. CONCERNS A FEMALE PT OF UNK AGE AND ORIGIN. MEDICAL HISTORY INCLUDED DIABETES. THE PT WAS TAKING AN UNSPECIFIED MEDIATION FOR TREATMENT OF AN UNK INDICATION. IN 2008, THE HUMAPEN MEMOIR WAS REPORTED TO BE STUCK IN THE RESET MODE AND THE DISPLAY HAD ALL DASHES IN IT THAT WERE NOT FLASHING AND WAS NOT ABLE TO RESET THE PEN. IT WAS REPORTED THAT TO THE LEFT ON THE DISPLAY THERE WERE FOUR TO FIVE DASHES AND TO THE RIGHT WERE TWO BOLDED DASHES. THE PEN WAS RETURNED TO THE MFR ON 12-SEP-2008 AND MISSING DOSE NUMBER SEGMENTS WERE IDENTIFIED. THIS HUMAPEN MEMOIR IS ASSOCIATED WITH PRODUCT COMPLAINT (LOT 0702C03). THE DEVICE WAS OPERATED BY THE PT. IT WAS UNK IF THE PT WAS TRAINED. NO USER ISSUES WERE IDENTIFIED. DURATION OF USE OF THE DEVICE WAS NOT REPORTED. UPDATE 06-OCT-2008: ADDITIONAL INFO RECEIVED 29-SEP-2008 VIA A FOLLOW-UP PRODUCT COMPLAINT ACTION ITEM. AMENDED MALFUNCTION DESCRIPTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMAPEN MEMOIR PEN INJECTOR FOR TREATMENT PURPOSE FMF ELI LILLY AND CO. MS9660 0702C03

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK