BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMAPEN ERGO, BURGUNDY/CLEAR

    MDR report key: 1172045 · Received September 17, 2008

    Report

    Report Number
    1819470-2008-00047
    Event Type
    Malfunction
    Date Received
    September 17, 2008
    Report Date
    August 20, 2008
    Manufacturer
    ELI LILLY AND COMPANY
    Product Code
    FMF
    PMA / PMN Number
    K982842
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTABLE MALFUNCTION/NEAR INCIDENT IDENTIFIED. INVESTIGATION IN PROGRESS. NOTE: THIS REPORT INCLUDES FINAL EVALUATION FINDINGS. NO ADDITIONAL INFORMATION IS EXPECTED. EVALUATION SUMMARY - 09-SEPTEMBER-2008, DEVICE SPECIFIC SAFETY SUMMARY: THE USER RETURNED THE ACTUAL COMPLAINT DEVICE TO THE MANUFACTURER FOR INVESTIGATION (LOT 0312A02, MANUFACTURED DECEMBER 2003). THE DEVICE WOULD NOT PRIME OR DOSE WITH THE COMPLAINT CARTRIDGE HOLDER ATTACHED. THE INVESTIGATION FOUND BOTH CLEAR CARTRIDGE HOLDER ENGAGEMENT TABS DEFORMED/BROKEN. THIS MALFUNCTION, BROKEN CLEAR CARTRIDGE HOLDER ENGAGEMENT TABS MAY RESULT IN AN UNDERDOSE. CORRECTIVE ACTION: THE CORE USER MANUAL STATES "DO NOT DAMAGE OR REMOVE THE CARTRIDGE HOLDER TABS. DO NOT USE THE PEN IF THE CARTRIDGE HOLDER TABS ARE BROKEN. DO NOT USE THE PEN IF ANY PART OF YOUR PEN APPEARS BROKEN OR DAMAGED. CONTACT (B) (4) AT XXX-XXX-XXXX OR YOUR HEALTHCARE PROFESSIONAL." IMPROPER USE AND STORAGE: THERE IS EVIDENCE OF NON-MANUFACTURING RELATED DAMAGE TO THE CARTRIDGE HOLDER ENGAGEMENT TABS. MARKS FROM AN UNKNOWN TOOL, ARE OBSERVED ON THE MOUNTING BAYONET AND ENGAGEMENT TAB AREAS. THE DAMAGE IS CONSISTENT WITH BENDING FATIGUE BY AN UNKNOWN TOOL. THIS BEHAVIOR IS CONSIDERED MISUSE AS IT IS PROHIBITED IN THE USER MANUAL.

    Description of Event or Problem · 1

    THIS DEVICE CASE, WHICH DOES NOT INVOLVE AN ADVERSE EVENT, REPORTED BY A CONSUMER, WHO CONTACTED THE COMPANY WITH A PRODUCT COMPLAINT, CONCERNS A (B) (6) (B) (6) MALE PATIENT. THE PATIENT WAS TAKING AN UNSPECIFIED MEDICATION FOR TREATMENT OF AN UNKNOWN INDICATION BEGINNING ON AN UNKNOWN DATE. ON (B) (6) 2008 THE HUMAPEN ERGO BURGUNDY/CLEAR PEN BODY (LOT 0312A02) WITH A CLEAR CARTRIDGE HOLDER ATTACHED WAS REPORTED BY THE PATIENT TO HAVE A BROKEN INJECTION BUTTON. THIS HUMAPEN ERGO BURGUNDY/CLEAR PEN BODY (LOT 0312A02) WITH A CLEAR CARTRIDGE HOLDER ATTACHED IS ASSOCIATED WITH 650919. THE OPERATOR OF THE DEVICE WAS UNKNOWN AND IT WAS UNKNOWN IF THE OPERATOR OF THE DEVICE WAS TRAINED. IT WAS UNKNOWN HOW LONG THE PATIENT HAD USED THIS DEVICE MODEL. THE DEVICE WAS RETURNED TO THE COMPANY ON (B) (6) 2008. INITIAL EXAMINATION FOUND TWO BROKEN ENGAGEMENT TABS ON THE CLEAR CARTRIDGE HOLDER. IT WAS UNKNOWN IF USE WITH ANOTHER HUMAPEN ERGO DEVICE WAS CONTINUED. FURTHER INFORMATION WILL BE ADDED WHEN RECEIVED. UPDATE 14-SEP-2008: ADDITIONAL INFORMATION RECEIVED ON 09-SEP-2008. ADDED: LSS ANALYSIS SUMMARY TO CASE, DEVICE MANUFACTURED DATE ADDED, IMPROPER USE / STORAGE CHANGED TO YES FROM NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMAPEN ERGO, BURGUNDY/CLEAR PEN INJECTOR FOR TREATMENT PURPOSE FMF ELI LILLY AND COMPANY MS8930 0312A02

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR