BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMAPEN MEMOIR

    MDR report key: 1842381 · Received September 23, 2010

    Report

    Report Number
    1819470-2010-00066
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Report Date
    September 9, 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

    NEW, UPDATED AND CORRECTED INFORMATION IS REFERENCED WITHIN THE UPDATE STATEMENTS. PLEASE REFER TO UPDATE STATEMENT DATED (B)(6) 2010. THIS REPORT INCLUDES FINAL EVALUATION FINDINGS. NO ADDITIONAL INFORMATION IS EXPECTED. EVALUATION SUMMARY THE CALLER STATED THE MEMOIR DEVICE HAD INCOMPLETE NUMBERS IN THE DISPLAY AND A RECURRING RESET MODE. THE DEVICE (LOT 0903C04, MANUFACTURED MARCH 2009) WAS RETURNED FOR INVESTIGATION. THE MANUFACTURER'S INVESTIGATION DID NOT CONFIRM THAT THERE WERE MISSING SEGMENTS IN THE DISPLAY. THE DISPLAY FUNCTIONED NORMALLY. THE INVESTIGATION DETERMINED THAT THE RECURRING RESET MODE RESULTED FROM A WEAK BATTERY. THE MALFUNCTION IS CONFIRMED. CORRECTIVE ACTION: BEGINNING WITH LOT1006C01 (MANUFACTURED OCT 2010), THE MANUFACTURER HAS CHANGED BATTERY SUPPLIERS AND IMPLEMENTED A NEW BATTERY IN THE DEVICE. THE USER MANUAL ADDRESSES PREMATURE EXPIRATION, PERMANENT ERRORS AND RESET MODE. THERE IS NO EVIDENCE OF IMPROPER USE OR STORAGE.

    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.

    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 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 WAS REPORTED TO HAVE INCOMPLETE NUMBERS IN THE DISPLAY. THIS HUMAPEN MEMOIR BURGUNDY PEN IS ASSOCIATED WITH PRODUCT COMPLAINT 1422826, LOT 0903C04. THE DEVICE WAS RETURNED. 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)(6) 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 CONSUMER, 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 WAS REPORTED TO HAVE INCOMPLETE NUMBERS IN THE DISPLAY. THIS HUMAPEN MEMOIR BURGUNDY PEN IS ASSOCIATED WITH PRODUCT COMPLAINT (B)(4), LOT 0903C04. 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. UPDATE (B)(6) 2010: ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2010 VIA THE PRODUCT COMPLAINT DATABASE, AND PROCESSED AT SAME TIME. CHANGED MALFUNCTION TYPE TO NOT CIRM, ADDED DEVICE SPECIFIC SAFETY SUMMARY, UPDATED EU/CA FIELDS, AND AMENDED NARRATIVE.

    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 0903C04

    Patients

    Seq Age Sex Outcome Treatment
    1