BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMAPEN ERGO, TEAL/CLEAR

    MDR report key: 444677 · Received February 25, 2003

    Report

    Report Number
    1819470-2003-00003
    Event Type
    Malfunction
    Date Received
    February 25, 2003
    Report Date
    February 2, 2003
    Manufacturer
    ELI LILLY AND CO.
    Product Code
    KZE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    IN 2002, THE PT WAS HOSPITALIZED AND STARTED ON HUMAN REGULAR INSULIN (HUMACART R) 22 UNITS DAILY (EIGHT UNITS IN MORNING AND AT NOON, EVENING SIX UNITS) VIA A HUMAPEN ERGO WITH CLEAR CARTRIDGE HOLDER (CCH) FOR THE TREATMENT OF DIABETES MELLITUS. THE PT DID NOT USE HUMAPEN ERGO PRIOR TO 2002. 2 MONTHS LATER, THE PT WAS ADMITTED TO A NURSING HOME AND STARTED TREATMENT AT THE REPORTER'S HOSP AS AN OUTPT (TREATMENT UNKNOWN). THE HUMAPEN ERGO CCH PROVIDED INSULIN CORRECTLY UNTIL 2003. HOWEVER, IN 2003, APPROXIMATELY FOUR MONTHS AFTER STARTING THE HUMAPEN ERGO CCH, THE PT COMPLAINED THAT THE PEN DID NOT PROVIDE INSULIN WHEN THEY PRIMED THE PEN. ACCORDING TO A STAFF MEMBER OF THE NURSING HOME, THE PT OFTEN REPLACED THE CAP OF THE PEN WITHOUT REMOVING THE PEN SHIELD. THE PT ORIGINALLY HAD A SHORT MEMORY AND NEEDED TO TAKE NOTES OF THEIR ACTION, AND THEY DID NOT REMEMBER WHAT THEY DID WHEN THE PEN WAS BROKEN. THE HUMAPEN ERGO CCH WAS REPLACED WITH A NEW PEN. THERE WAS NOT A PROBLEM WITH THE NEW PEN. NO ADVERSE EVENT WAS EXPERIENCED. THE OPERATOR OF THE PEN WAS THE PT AND THEY WERE A TRAINED USER. THE PT PRIMED THE PEN PROPERLY EVERY TIME THEY RECEIVED AN INJECTION. THE DURATION OF PEN USAGE WAS APPROXIMATELY FOUR MONTHS. THIS DEVICE COMPLAINT IS ASSOCIATED WITH CID166035. IN 2003, THE AFFILIATE INITIAL ANALYSIS REVEALED TWO ENGAGEMENT TABS ON THE HUMAPEN ERGO CCH WERE BROKEN. THE HUMAPEN ERGO CCH WILL BE RETURNED TO THE MFR FOR FURTHER ANALYSIS. FEB 2003: RESULTS/CONCLUSIONS: THE MFR INVESTIGATION CONFIRMED THAT THE COMPLAINT DEVICE HAD TWO BROKEN ENGAGEMENT TABS AND THE NEEDLE SHEATH WAS STUCK IN THE CAP. IT WAS NOTED THAT THE LEFT AND RIGHT ENGAGEMENT TABS WERE REMOVED WHILE IN THE FIELD. THE RIGHT ENGAGEMENT TAB DAMAGE WAS CONSISTENT WITH REMOVAL BY AN UNKNOWN CUTTING TOOL. THE LEFT ENGAGEMENT TAB DAMAGE WAS CONSISTENT WITH PARTIAL REMOVAL BY AN UNKNOWN CUTTING TOOL WITH PARTIAL FAILURE FROM BENDING FATIGUE. THE ROOT CAUSE FOR THE BROKEN ENGAGEMENT TABS WAS DAMAGE INCURRED WHILE IN THE FIELD. THE NEELE SHEATH REPORTED DIFFICULTY WAS DUE TO IMPROPER USE OF THE PRODUCT. THE USER MANUAL INSTRUCTS THE USER TO REMOVE THE NEEDLE PRIOR TO REPLACING THE CAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMAPEN ERGO, TEAL/CLEAR PEN INJECTOR KZE ELI LILLY AND CO. MS8929 40171

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR