BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMAPEN ERGO, BURGUNDY/CLEAR

    MDR report key: 1505245 · Received September 23, 2009

    Report

    Report Number
    1819470-2009-00048
    Event Type
    Malfunction
    Date Received
    September 23, 2009
    Report Date
    August 25, 2009
    Manufacturer
    ELI LILLY AND CO.
    Product Code
    FMF
    PMA / PMN Number
    K982842
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTABLE MALFUNCTION/NEAR INCIDENT IDENTIFIED. INVESTIGATION IS PROGRESS. THIS REPORT INCLUDES FINAL EVALUATION FINDINGS. NO ADD'L INFO IS EXPECTED. EVALUATION SUMMARY: THE USER RETURNED THE ACTUAL COMPLAINT DEVICE FOR INVESTIGATION (LOT 0404A04, MANUFACTURED APRIL 2004). THE MANUFACTURER'S INVESTIGATION FOUND A REAR OUTER HOUSING (ROH) TO FRONT OUTER HOUSING (FOH) COMPLETE GLUE BOND SEPARATION. THIS MALFUNCTION RENDERS THE DEVICE UNUSABLE. IN ADDITION, BOTH CLEAR CARTRIDGE HOLDER ENGAGEMENT TABS WERE BROKEN. THIS MALFUNCTION CAN RESULT IN AN UNDERDOSE. CORRECTIVE ACTION, ROH TO FOH SEPARATION: THE GLUE BOND STATION WAS OPTIMIZED BEGINNING WITH BATCH 0310A03 ((B)(4) 2003) WHICH WAS BEFORE THIS REPORTED BATCH, 0404A04 (APRIL 2004) HOWEVER, EXCESSIVE FORCES IN THE FIELD MAY CAUSE THE FOH TO ROH JOINT TO BREAK. 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. NO FURTHER CORRECTIVE ACTIONS ARE PLANNED AS THE DEVICE MANUFACTURING WAS DISCONTINUED DECEMBER 2006. IMPROPER USE AND STORAGE: THERE IS EVIDENCE OF NON-MANUFACTURING DAMAGE TO THE CLEAR CARTRIDGE HOLDER. THE INVESTIGATION FOUND TOOL MARKS ON THE MOUNTING BAYONET AND ENGAGEMENT TAB AREAS. THIS DAMAGE IS CONSISTENT WITH REMOVING THE ENGAGEMENT TABS WITH PLIERS.

    Description of Event or Problem · 1

    THIS DEVICE CASE, WHICH DOES NOT INVOLVE AN ADVERSE EVENT, REPORTED BY A CONSUMER VIA A SALES REPRESENTATIVE, WHO CONTACTED THE COMPANY WITH A PRODUCT COMPLAINT, CONCERNS AN ASIAN FEMALE PT OF UNK AGE. THE PT WAS TAKING AN UNSPECIFIED MEDICATION FOR TREATMENT OF AN UNK INDICATION. ON (B)(6) 2009, THE HUMAPEN ERGO BURGUNDY/CLEAR PEN BODY (LOT 0404A04) WITH A CLEAR CARTRIDGE HOLDER ATTACHED WAS REPORTED TO HAVE BROKEN CARTRIDGE HOLDER. THIS HUMAPEN ERGO BURGUNDY/ CLEAR PEN BODY WITH A CLEAR CARTRIDGE HOLDER ATTACHED WAS ASSOCIATED WITH COMPLAINT NUMBER (B)(4). THE OPERATOR OF THE DEVICE WAS UNK AND IT WAS UNK IF THE OPERATOR OF THE DEVICE WAS TRAINED. IT WAS UNK HOW LONG PT HAD USED THIS DEVICE MODEL. THE DEVICE WAS RETURNED TO THE COMPANY ON (B)(6) 2009. INITIAL EXAMINATION FOUND TWO BROKEN ENGAGEMENT TABS. IT WAS UNK IF THIS HUMAPEN ERGO BURGUNDY/CLEAR PEN BODY WITH A CLEAR CARTRIDGE HOLDER ATTACHED WAS CONTINUED. REFER TO RESULTS/CONCLUSIONS SECTION. UPDATE (B)(4) 2009: ADD'L INFO RECEIVED ON (B)(4) 2009. ADDED LSS SUMMARY TO QC INFO TAB; UPDATED FINAL FIELDS, FURTHER INVESTIGATION FIELD AND DELETED EXPECTED F/U DATE ON EU/CA DEVICE BUTTON; SELECTED IMPROPER USE AND STORAGE AS YES IN CORRESPONDING FIELD AND ADDED 'REFER TO RESULTS/CONCLUSIONS SECTION' TO NARRATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMAPEN ERGO, BURGUNDY/CLEAR PEN INJECTOR FOR TREATMENT PURPOSES FMF ELI LILLY AND CO. MS8930 0404A04

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK