BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMAPEN ERGO, TEAL/CLEAR

    MDR report key: 550804 · Received April 16, 2004

    Report

    Report Number
    1819470-2004-00006
    Event Type
    Malfunction
    Date Received
    April 16, 2004
    Report Date
    March 9, 2004
    Manufacturer
    ELI LILLY AND CO.
    Product Code
    NSC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    WHILE THE PT WITH TYPE II DIABETES MELLITUS WAS RECEIVING TRAINING IN USING UNSPECIFIED TYPE OF HUMAN INSULIN VIA A HUMAPEN ERGO TEAL/CLEAR PEN BODY WITH A CLEAR CARTRIDGE HOLDER (CCH) ATTACHED (LOT #030326JP), THE DRUG DID NOT COME OUT OF THE PEN AT THE TIME OF PRIMING. AFTER A FEW MINUTES, THE PT COMPLAINED THAT THE PEN WAS POSSIBLY BROKEN. THE PHARMACIST THEN FOUND THAT BOTH ENGAGEMENT TABS OF THE CARTRIDGE HOLDER WERE LOST. THEREFORE, THE CLEAR CARTRIDGE HOLDER WAS REPLACED TO ANOTHER CARTRIDGE, AND THE TRAINING WAS COMPLETED WITHOUT PROBLEMS. NO ADVERSE EVENTS WERE EXPERIENCED. THE PT OPERATED THE PEN AND STORED IT AT ROOM TEMPERATURE. THE EXPIRATION DATE WAS NOT PROVIDED. THE REPORTING PHARMACIST DECLINED TO PROVIDE FURTHER INFO, THEREFORE, NO FURTHER FOLLOW-UP WOULD BE ATTEMPTED. THE DEVICE WAS RETURNED TO THE CO ON 11-MAR-2004. INITIAL ANALYSIS BY THE AFFILIATE QUALITY CONTROL DEPARTMENT FOUND: TWO BROKEN ENGAGEMENT TABS. THERE WERE TRACES THAT THE CCH TABS WERE CUT BY LIKE SCISSORS. INITIAL ANALYSIS BY THE MFG SITE QUALITY CONTROL DEPT FOUND TWO BROKEN ENGAGEMENT TABS, ONLY THE CARTRIDGE HOLDER WAS RETURNED: THE PDS INVESTIGATION OF THE RETURNED CCH FOUND BOTH TABS BROKE. THE CARTRIDGE HOLDER HAS BEEN ROUTED FOR FURTHER INVESTIGATION (RFI).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMAPEN ERGO, TEAL/CLEAR PEN INJECTOR NSC ELI LILLY AND CO. MS8929 030326JP

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR