BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMAPEN MEMOIR

    MDR report key: 1883767 · Received October 27, 2010

    Report

    Report Number
    1819470-2010-00087
    Event Type
    Malfunction
    Date Received
    October 27, 2010
    Report Date
    September 28, 2010
    Manufacturer
    ELI LILLY AND COMPANY
    Product Code
    NSC
    PMA / PMN Number
    K053563
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THIS REPORT INCLUDES FINAL EVALUATION FINDINGS. NO ADDITIONAL INFORMATION IS EXPECTED. EVALUATION SUMMARY A USER REPORTED THAT THE DISPLAY OF HIS MEMOIR PEN DEVICE WAS NOT SHOWING THE DIGITS COMPLETELY. THE DEVICE WAS RETURNED FOR INVESTIGATION (BATCH 1003C02, MANUFACTURED MARCH 2010). A DETAILED INVESTIGATION CONFIRMED MISSING SEGMENTS IN THE DOSE DIGITS AND DETERMINED THE ROOT CAUSE IS A DEFICIENT BOND BETWEEN THE CABLE AND THE LCD GLASS. 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 AT XXX-XXX-XXXX OR YOUR HEALTHCARE PROFESSIONAL. CORRECTIVE ACTION DEFICIENT BOND - A SPECIFIC CORRECTIVE ACTION HAS NOT YET BEEN IMPLEMENTED. HOWEVER, AN INVESTIGATION HAS BEEN INITIATED TO EVALUATE DIFFERENT OPTIONS TO REDUCE THE OCCURRENCE OF DEFICIENT BONDS. 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 WITH A PRODUCT COMPLAINT, CONCERNS A PATIENT OF UNKNOWN AGE, GENDER, OR ORIGIN. THE PATIENT WAS TAKING AN UNSPECIFIED MEDICATION FOR TREATMENT OF AN UNKNOWN INDICATION. ON (B)(6) 2010, THE HUMAPEN MEMOIR BURGUNDY PEN BODY WAS REPORTED TO HAVE INCOMPLETE DIGITS IN THE DISPLAY. THIS HUMAPEN MEMOIR BURGUNDY PEN BODY WITH A CLEAR CARTRIDGE HOLDER ATTACHED WAS ASSOCIATED WITH PRODUCT COMPLAINT (B)(4), LOT 0712C02. NO VISUAL OR FUNCTION ANALYSIS WAS PROVIDED FOR THE RETURNED DEVICE AT THE TIME OF THE INITIAL REPORT. THE OPERATOR OF THE DEVICE WAS UNKNOWN. IT WAS UNKNOWN IF THE USER WAS TRAINED. THIS DEVICE MODEL WAS USED FOR AN UNSPECIFIED LENGTH OF TIME. THE DEVICE WAS RETURNED ON (B)(4) 2010. THE HUMAPEN MEMOIR BURGUNDY WAS NOT CONTINUED.

    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 WITH A PRODUCT COMPLAINT, CONCERNS A PATIENT OF UNKNOWN AGE, GENDER, OR ORIGIN. THE PATIENT WAS TAKING AN UNSPECIFIED MEDICATION FOR TREATMENT OF AN UNKNOWN INDICATION. ON (B)(6)-2010, THE HUMAPEN MEMOIR BURGUNDY PEN BODY WAS REPORTED TO HAVE INCOMPLETE DIGITS IN THE DISPLAY. THIS HUMAPEN MEMOIR BURGUNDY PEN BODY WITH A CLEAR CARTRIDGE HOLDER ATTACHED WAS ASSOCIATED WITH PRODUCT COMPLAINT (B)(4), LOT 0712C02. NO VISUAL OR FUNCTION ANALYSIS WAS PROVIDED FOR THE RETURNED DEVICE AT THE TIME OF THE INITIAL REPORT. THE OPERATOR OF THE DEVICE WAS UNKNOWN. IT WAS UNKNOWN IF THE USER WAS TRAINED. THIS DEVICE MODEL WAS USED FOR AN UNSPECIFIED LENGTH OF TIME. THE DEVICE WAS RETURNED ON (B)(4)-2010. THE HUMAPEN MEMOIR BURGUNDY WAS NOT CONTINUED. UPDATE (B)(4)-2010: ADDITIONAL INFORMATION WAS RECEIVED ON (B)(4)-2010 FROM THE PRODUCT COMPLAINT SAFETY DATABASE. LOT NUMBER 0712C02 WAS CORRECTED TO 1003C02. UPDATED PRODUCT TAB FOR HUMAPEN MEMOIR BURGUNDY AND UPDATED THE NARRATIVE WITH THE CHANGE. UPDATE (B)(4)-2010: ADDITIONAL INFORMATION RECEIVED (B)(4)-2010 VIA GLOBAL PRODUCT COMPLAINT DATABASE. ADDED DEVICE SPECIFIC SAFETY SUMMARY AND UPDATED EU/CA DEVICE FIELDS.

    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 1003C02

    Patients

    Seq Age Sex Outcome Treatment
    1