BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMAPEN ERGO, TEAL/CLEAR

    MDR report key: 1370076 · Received February 26, 2009

    Report

    Report Number
    1819470-2009-00008
    Event Type
    Malfunction
    Date Received
    February 26, 2009
    Report Date
    January 28, 2009
    Manufacturer
    ELI LILLY AND CO.
    Product Code
    FMF
    PMA / PMN Number
    K982842
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTABLE MALFUNCTION/NEAR INCIDENT IDENTIFIED. INVESTIGATION IN PROGRESS. NOTE: THIS REPORT INCLUDES FINAL EVAL FINDINGS. NO ADD'L INFO IS EXPECTED. EVAL SUMMARY: THE USER RETURNED THE ACTUAL COMPLAINT DEVICE TO THE MFR FOR INVESTIGATION (LOT 40005, MFG IN 01/2001). THE INVESTIGATION FOUND BOTH CLEAR CARTRIDGE HOLDER ENGAGEMENT TABS BROKEN. THIS MALFUNCTION MAY CAUSE AN UNDERDOSE. CORRECTIVE ACTION, CLEAR CARTRIDGE HOLDER TABS BROKEN: 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 LILLY AT XXXXXXXXXX, OR YOUR HEALTHCARE PROFESSIONAL." NO FURTHER CORRECTIVE ACTIONS ARE PLANNED, AS THE DEVICE MFG WAS DISCONTINUED 12/2006. IMPROPER USE AND STORAGE: THERE IS EVIDENCE OF IMPROPER USE. OBSERVED ON BOTH ENGAGEMENT TAB AREAS ARE MARKS CONSISTENT WITH BREAKAGE BY FILING AND FINGERNAIL CLIPPERS. THIS MISUSE IS RELEVANT TO THE USER'S COMPLAINT AND THE INVESTIGATION FINDINGS. ALSO, THE USER DOES NOT PRIME THE DEVICE BEFORE EACH USE. HOWEVER, THIS MISUSE IS NOT RELEVANT TO THE USER'S COMPLAINT OR INVESTIGATION FINDINGS.

    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 MALE PT OF UNK AGE OR ORIGIN. THE PT WAS RECEIVING AN UNSPECIFIED MEDICATION FOR TREATMENT OF UNK INDICATION. ON (B)(6) 2008, THE HUMAPEN ERGO TEAL/CLEAR PEN BODY (LOT 40005) WITH A CLEAR CARTRIDGE HOLDER ATTACHED (LOT NOT PROVIDED) WAS REPORTED TO HAVE ONE ENGAGEMENT TAB BROKEN. AFTER FURTHER REVIEW, BOTH CLEAR CARTRIDGE HOLDER ENGAGEMENT TABS WERE FOUND BROKEN. THIS HUMAPEN ERGO TEAL/CLEAR PEN BODY WITH A CLEAR CARTRIDGE HOLDER ATTACHED IS ASSOCIATED WITH PC813554. IT WAS UNK WHO OPERATED THE DEVICE. THE OPERATOR WAS TRAINED BY PHYSICIAN. IT WAS UNK HOW LONG THE DEVICE MODEL HAD BEEN USED. THE REPORTED DEVICE HAD BEEN USED FOR ABOUT 7 YRS. THE RETURN OF THE DEVICE WAS ANTICIPATED. IT WAS UNK IF THE HUMAPEN ERGO TEAL/CLEAR PEN BODY WITH A CLEAR CARTRIDGE HOLDER ATTACHED WAS SWITCHED BY ANOTHER DEVICE. UPDATE 02/19/2009: ADD'L INFO FROM QUALITY ON 02/12/2009: CHANGE THE MALFUNCTION FROM CIRM TO NOT CIRM. ADDED INFO THAT AFTER FURTHER REVIEW, BOTH ENGAGEMENT TABS WERE FOUND DAMAGED, ONE SPRING ARM BROKEN, AND ONE SPRING ARM CRACKED, THE DEVICE PASSED IN FUNCTIONAL TESTING. UPDATED CORRESPONDING FIELDS AND NARRATIVE. UPDATE 02/26/2009: ADD'L INFO FROM QUALITY ON 02/20/2009: CHANGE THE MALFUNCTION FROM NOT CIRM TO CIRM. ADDED INFO THAT AFTER FURTHER REVIEW BOTH ENGAGEMENT TABS WERE FOUND BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMAPEN ERGO, TEAL/CLEAR PEN INJECTOR FOR TREATMENT PURPOSES FMF ELI LILLY AND CO. MS8929 40005

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK