BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMAPEN ERGO, TEAL/CLEAR

    MDR report key: 757150 · Received November 8, 2005

    Report

    Report Number
    1819470-2005-00020
    Event Type
    Malfunction
    Date Received
    November 8, 2005
    Report Date
    October 20, 2005
    Manufacturer
    ELI LILLY AND CO.
    Product Code
    KZE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S PRELIMINARY COMMENTS: THE CONTENTS OF THE COMPLAINT NARRATIVE SUGGEST THAT THIS 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 REPORTED MALFUNCTION/NEAR INCIDENT HAS OCCURRED. ADDITIONAL MANUFACTURER NARRATIVE: 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 FEMALE 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 TEAL/CLEAR PEN FOR THE TREATMENT OF DIABETES. ON AN UNSPECIFIED DATE, THE CARTRIDGE HOLDER TABS BROKE ON THE HUMAPEN ERGO TEAL/CLEAR PEN (LOT NUMBER 0402A03). THE PATIENT HAD THE PEN FOR ROUGHLY ONE YEAR. THE TABS BROKE, WHILE ATTACHED TO THE PEN. THE PATIENT SAID, :"THEY BROKE QUITE EASILY." THE TYPE OF NEEDLE TIPS USED WAS UNK. IT IS NOT KNOWN IF THE UNK OPERATOR OF THE DEVICE WAS A TRAINED USER. THE RETURN OF THE HUMAPEN ERGO TEAL/CLEAR PEN IS ANTICIPATED. THIS HUMAPEN ERGO TEAL/CLEAR PEN COMPLAINT IS ASSOCIATED WITH CID003496000. UPDATE 06-NOV-2005: RECEIVED INFORMATION VIA PRODUCT COMPLAINT FOLLOW UP QUERY NOTIFICATION ON 01-NOV-2005. CHECKED PHV REVIEWED BOX. NO NEW INFORMATION ADDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMAPEN ERGO, TEAL/CLEAR PEN INJECTOR KZE ELI LILLY AND CO. MS8929 0402A03

    Patients

    Seq Age Sex Outcome Treatment
    1