BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMAPEN MEMOIR

    MDR report key: 1082402 · Received July 25, 2008

    Report

    Report Number
    1819470-2008-00040
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Report Date
    June 25, 2008
    Manufacturer
    ELI LILLY AND COMPANY
    Product Code
    FMF
    PMA / PMN Number
    K053563
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 COMPANY IDENTIFIED REPORTABLE MALFUNCTION (CIRM) ONLY CASE REPORTED BY A CONSUMER, CONCERNED A MALE PATIENT OF UNKNOWN AGE AND ORIGIN. THE PATIENT RECEIVED AN UNSPECIFIED DRUG PRODUCT VIA A HUMAPEN (HP)) MEMOIR; BURGUNDY REUSABLE DEVICE, DOSING REGIMEN UNSPECIFIED, FOR THE TREATMENT OF AN UNSPECIFIED INDICATION, BEGINNING ON AN UNSPECIFIED DATE. ON (B) (6) 2008, THE PATIENT REPORTED THAT HE HAD A MEMOIR PEN AND SOME OF THE SEGMENTS WERE NOT COMING UP. THE PATIENT STATED THAT WHEN HE TURNED ON THE DISPLAY, SOME OF THE SEGMENTS WERE MISSING. HE SAID THAT THE ZERO WAS NOT A ZERO, LIKE "U" SHAPED AND HAD THE TOP LIKE A STAPLE AND THEN NOTHING AND ON THE BOTTOM WAS A LINE GOING HORIZONTALLY. THAT WAS WHAT APPEARED WHEN TURNING IT ON, WHEN HE TURNED IT FOR UNITS, THE NUMBERS CAME UP BUT SOME OF THE PARTS WERE MISSING, LIKE THE NUMBER ONE PART OF IT WAS GONE, TWO TO FOUR WAS GOOD, FIVE LOOKED LIKE AND "E", SEVEN WAS NOT A SEVEN. HE STATED THAT THE PEN STILL DIALS AND WOULD LISTEN TO THE CLICKS AND HAD BEEN USING THE PEN. HE STATED THAT THE PEN WAS NOT THAT OLD AND HE ONLY HAD IT FOR SIX MONTHS ((B) (6) 2007). THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS. LOT NUMBER FOR THE HP MEMOIR: BURGUNDY REUSABLE DEVICE WAS 0702C03 ((B) (4)). IT WAS UNKNOWN IF THE PATIENT WAS A TRAINED USER OF THE DEVICE. GENERAL DEVICE AND PROBLEM DEVICE DURATION OF USE WAS NOT PROVIDED. IN A SEPARATE REPORT ON 10-JUL-2008, THE PATIENT STATED THAT THE SUSPECT DEVICE WAS WORKING AGAIN AND HE BELIEVED THE PROBLEM WITH THE PEN WAS DUE TO HEAT. THE PATIENT STATED THAT HE LEFT THE PEN IN HIS CAR FOR A FEW HOURS AND IT WAS HOT. THE COMPANY RECEIVED THE SUSPECT DEVICE ON 14-JUL-2008. UPDATE 23-JUL-2008: UPON REVIEW, IT WAS DETERMINED THAT THE PATIENT'S DATE OF BIRTH WAS NOT REPORTED AND WAS DELETED FROM THE CASE. UPDATED NARRATIVE AND CORRESPONDING FIELD WITH THE CHARGES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK