BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMAPEN ERGO, BURG/CLEAR

    MDR report key: 765991 · Received November 1, 2005

    Report

    Report Number
    1819470-2005-00019
    Event Type
    Malfunction
    Date Received
    November 1, 2005
    Report Date
    October 4, 2005
    Manufacturer
    ELI LILLY AND CO.
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONTENT OF THE COMPLAINT NARRATIVE SUGGEST THAT THE DEVICE MAY HAVE HAD BOTH ENGAGEMENT TABS BROKE. HOWEVER, THIS CANNOT BE CONFIRMED WITHOUT THE DEVICE. IN THE EVENT THE DEVICE IS RETURNED, IT WILL BE EVALUATED TO DETERMINE IF A REPORTABLE MALFUNCTION/NEAR INCIDENT HAS OCCURRED. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE FINAL EVALUATION IS COMPLETED.

    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 PATIENT. THE PATIENT'S MEDICAL HISTORY WAS NOT PROVIDED. IT IS NOT KNOWN IF THE PATIENT RECEIVED ANY CONCOMITANT MEDICATIONS. THE PATIENT RECEIVED AN UNSPECIFIED MEDICATION VIA A HUMAPEN ERGO BURGUNDY/CLEAR PEN FOR THE TREATMENT OF DIABETES. THE PATIENT WANTED TO KNOW HOW TO OBTAIN A NEW CARTRIDGE HOLDER AS WELL AS A NEW CARRYING CASE FOR HIS HUMAPEN. THE CLEAR CARTRIDGE HOLDER THAT WAS ATTACHED TO THE PATIENT'S DEVICE WAS LOOSE AND THE TABS HAD BROKEN OFF. THE DURATION OF USE AND AGE OF THE HUMAPEN ERGO BURGUNDY/CLEAR PEN WAS APPROXIMATELY EIGHT TO NINE YEARS. IT WAS RECOMMENDED TO THE PATIENT TO REPLACE HIS DEVICE EVERY THREE YEARS. THE PATIENT HAD DIFFICULTY READING THE LOT NUMBER OFF OF THE DEVICE AND PROVIDED A LOT NUMBER OF 40108. THE PATIENT USED BD ULTRA FINE III (31 GAUGE; 8 MM) NEEDLE TIPS. THE PATIENT OPERATED THE DEVICE. IT IS NOT KNOWN IF THE PATIENT WAS A TRAINED DEVICE USER. THE PATIENT REUSED NEEDLE TIPS THREE TO FOUR TIMES BEFORE CHANGING THEM. THE PATIENT DID NOT PRIME EVERY TIME HE INJECTED. THE PATIENT WAS ADVISED ON PROPER NEEDLE USE AND THE IMPORTANCE OF PRIMING. IT IS NOT KNOWN HOW THE HUMAPEN ERGO BURGUNDY CLEAR PEN WAS STORED. THE PATIENT WAS ADVISED TO OBTAIN A NEW PEN FROM HIS LOCAL PHARMACY. THE RETURN OF THE HUMAPEN ERGO BURGUNDY/CLEAR PEN IS ANTICIPATED. ATTEMPTED TO OBTAIN LOT/CONTROL NUMBER; NUMBER PROVIDED WAS NOT A VALID LOT NUMBER FOR THE DEVICE. UPDATE 18 OCT 2005 RECEIVED INFORMATION VIA PRODUCT COMPLAINT FOLLOW UP QUERY NOTIFICATION ON 13 OCT 2005. CHECKED PHV REVIEWED BOX. NO NEW INFORMATION ADDED. UPDATE 26 OCT 2005: RECEIVED INFORMATION VIA PRODUCT COMPLAINT FOLLOW UP QUERY NOTIFICATION ON 19 OCT 2005 CHECKED PHV REVIEWED BOX. ADDED LOT NUMBER TO SUSPECT DEVICE LOT NUMBER FIELD NARRATIVE AND COMMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMAPEN ERGO, BURG/CLEAR PEN INJECTOR FMF ELI LILLY AND CO. MS8930 40108

    Patients

    Seq Age Sex Outcome Treatment
    1 *