BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMAPEN MEMOIR

    MDR report key: 2862666 · Received December 10, 2012

    Report

    Report Number
    1819470-2012-00089
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Report Date
    November 9, 2012
    Manufacturer
    ELI LILLY AND COMPANY
    Product Code
    NSC
    PMA / PMN Number
    K053563
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER FOLLOW UP IS PLANNED. EVALUATION SUMMARY A PATIENT REPORTED THAT THE NUMBERS OF HER HUMAPEN MEMOIR DEVICE DISPLAY ARE NOT SHOWING PROPERLY AS SEGMENTS ARE MISSING. INVESTIGATION OF THE RETURNED DEVICE (BATCH (B)(4), MANUFACTURED MAY 2008) FOUND MISSING DOSE SEGMENTS AND DATE AND TIME SEGMENTS DUE THE BREAKAGE OF THE LCD DUE TO AN IMPACT LOAD TO THE LENS WHILE IN THE FIELD. 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. THERE IS EVIDENCE OF IMPROPER USE OR STORAGE. THE MOST PROBABLE CAUSE FOR BREAKAGE OF THE LCD WAS A MECHANICAL IMPACT LOAD TO THE PEN WHILE IN THE FIELD. THE OBSERVED DAMAGE TO THE DEVICE WAS ATYPICAL WITH NORMAL USE.

    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.

    Description of Event or Problem · 1

    (B)(6). THIS DEVICE CASE, WHICH DOES NOT INVOLVE AN ADVERSE EVENT, REPORTED BY A CONSUMER WHO CONTACTED THE COMPANY TO REPORT A PRODUCT COMPLAINT, REGARDS A FEMALE PATIENT OF UNSPECIFIED AGE, AND ORIGIN. THE PATIENT WAS TAKING INSULIN LISPRO (HUMALOG) FOR AN UNKNOWN INDICATION. ON (B)(6) 2012, IT WAS REPORTED THAT THE PATIENT'S HUMAPEN MEMOIR DISPLAY WAS NOT SHOWING PROPERLY AND SEGMENTS WERE MISSING. THE HUMAPEN MEMOIR WAS ASSOCIATED WITH PRODUCT COMPLAINT 2394962/ LOT 0805C02. THE PATIENT WAS THE USER OF THE PEN. THE USER'S TRAINING STATUS WAS NOT PROVIDED. THE DURATION OF USE WAS NOT PROVIDED. UPON RETURN OF THE DEVICE ON (B)(4) 2012, IT WAS NOTED THAT THE PEN HAD A CRACKED SCREEN.

    Description of Event or Problem · 1

    (B)(4). THIS DEVICE CASE, WHICH DOES NOT INVOLVE AN ADVERSE EVENT, REPORTED BY A CONSUMER WHO CONTACTED THE COMPANY TO REPORT A PRODUCT COMPLAINT, REGARDS A FEMALE PATIENT OF UNSPECIFIED AGE, AND ORIGIN. THE PATIENT WAS TAKING INSULIN LISPRO (HUMALOG) FOR AN UNKNOWN INDICATION. ON (B)(6) 2012, IT WAS REPORTED THAT THE PATIENT'S HUMAPEN MEMOIR DISPLAY WAS NOT SHOWING PROPERLY AND SEGMENTS WERE MISSING. THE HUMAPEN MEMOIR WAS ASSOCIATED WITH PRODUCT COMPLAINT (B)(4)/ LOT 0805C02 MANUFACTURED 31-MAY-2008. THE PATIENT WAS THE USER OF THE PEN. THE USER'S TRAINING STATUS WAS NOT PROVIDED. THE DURATION OF USE WAS NOT PROVIDED. UPON RETURN OF THE DEVICE ON (B)(6) 2012, IT WAS NOTED THAT THE PEN HAD A CRACKED SCREEN. UPDATE (B)(4) 2012: ADDITIONAL INFORMATION WAS RECEIVED ON (B)(4) 2012 FROM THE GLOBAL PRODUCT COMPLAINT DATABASE. ADDED DATE OF MANUFACTURE TO THE SUSPECT DEVICE AND DEVICE SPECIFIC SAFETY SUMMARY DETAILS. UPDATED IMPROPER USE OR STORAGE FROM NO TO YES, NARRATIVE, MEDWATCH FIELDS AND EU/CA FIELDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMAPEN MEMOIR FOR TREATMENT PURPOSES NSC ELI LILLY AND COMPANY MS9660 0805C02

    Patients

    Seq Age Sex Outcome Treatment
    1 HUMALOG