BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMAPEN ERGO, BURG/CLEAR

    MDR report key: 473124 · Received July 11, 2003

    Report

    Report Number
    1819470-2003-00020
    Event Type
    Malfunction
    Date Received
    July 11, 2003
    Report Date
    June 13, 2003
    Manufacturer
    ELI LILLY AND CO.
    Product Code
    FMF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    THIS DEVICE CASE, WHICH DOES NOT INVOLVE AN ADVERSE EVENT, REPORTED BY A NON-HEALTHCARE PROFESSIONAL, WHO CONTACTED THE CO TO REPORT A PRODUCT COMPLAINT, CONCERNS A PT OF UNK SEX OR AGE. THE PT'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE PT WAS RECEIVING HUMAN INSULIN VIA A HUMAPEN ERGO BURGENDY/CLEAR PEN BODY (LOT 40224) WITH A CLEAR CARTRIDGE HOLDER ATTACHED, FOR THE TREATMENT OF DIABETES. THE PERSON OPERATING THE DEVICE WAS THE PT. IT IS UNK IF THE OPERATOR OF THE DEVICE WAS TRAINED. THE PEN WAS REPORTED TO BE ONE YEAR OLD AND THE REPORTER IDENTIFIED TWO BROKEN ENGAGEMENT TABS. THIS HUMAPEN ERGO COMPLAINT IS ASSOCIATED WITH CID00185724. THE DEVICE WAS RETURNED TO THE CO. INITIAL ANALYSIS BY THE AFFILIATE QUALITY CONTROL DEPT FOUND THAT THE GENERAL CONDITION OF THE PEN WAS GOOD. THE PEN HAD A CLEAR CARTRIDGE HOLDER WITH TWO BROKEN ENGAGEMENT TABS, NO PART OF THE TABS WAS INTACT WITH ALMOST SHEAR BREAKAGE ON BOTH. THE PRODUCT IS OUT OF SPECIFICATION FOR DOSE ACCURACY. TWO TAB BREAKAGE HAS BEEN SHOWN TO DELIVER AN UNDERDOSE OF INSULIN. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR ADDITIONAL EVALUATION. THE COMPLAINT DEVICE WAS RETURNED IN CONDITION THAT WAS NOT POSSIBLE TO TEST. ANALYSIS CATEGORY: CARTRIDGE HOLDER BOTH ENGAGEMENT TABS BROKEN - POSSIBLE UNDERDOSE. CORRECTIVE ACTION/REASON FOR NO CORRECTIVE ACTION: NO CORRECTIVE ACTION RECOMMENDED, AS THE CAUSE FOR THE COMPLAINT IS DAMAGE WHILE IN THE FIELD. DEFECTS THAT DO NOT IMPACT PERFORMANCE SPECIFICATIONS ON THIS PEN: ONE CRACKED SPRING ARM. STORAGE AND USAGE: THERE IS EVIDENCE OF IMPROPER USE/STORAGE: BASED ON THE ENGINEERING INVESTIGATION AND TECHNICAL REPORT, BOTH ENGAGEMENT TABS WERE CUT OFF AT BASE WITH UNK TOOL WHILE IN THE FIELD. UPDATE 26-JUN-2003: INITIAL GPCMS REPORT RECEIVED FROM QA ON THE 20-JUN-2003, TWO TAB BREAKAGE CONFIRMED. INITIAL COMMENTS ADDED AND CASE UPDATED ACCORDINGLY. UPDATE 27-JUN-2003: INFO RECEIVED VIA PC FOLLOW UP TOOL. CASE REVIEWED, NO CHANGES TO CASE MADE. UPDATE 10-JUL-2003: FINAL GPCMS REPORT RECEIVED ON THE 09-JUL-2003, FINAL COMMENTS ADDED AND CASE UPDATED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMAPEN ERGO, BURG/CLEAR PEN INJECTOR FMF ELI LILLY AND CO. MS8930 40224

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO