BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMAPEN ERGO BURGUNDY/CLEAR/CLEAR CH

    MDR report key: 1370078 · Received February 26, 2009

    Report

    Report Number
    1819470-2009-00007
    Event Type
    Malfunction
    Date Received
    February 26, 2009
    Report Date
    January 28, 2009
    Manufacturer
    ELI LILLY AND CO.
    Product Code
    FMF
    PMA / PMN Number
    K982842
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTABLE MALFUNCTION/NEAR INCIDENT IDENTIFIED. INVESTIGATION IN PROGRESS. NOTE: THIS IS AN INITIAL REPORT. A F/U REPORT WILL BE SUBMITTED WHEN THE FINAL EVAL 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 PT, AGE NOT PROVIDED. THE PT WAS TAKING AN UNSPECIFIED MEDICATION FOR TREATMENT OF AN UNK INDICATION. ON (B)(6) 2009, THE HUMAPEN ERGO BURGUNDY/CLEAR PEN BODY (LOT 0603A04) WITH A CLEAR CARTRIDGE HOLDER ATTACHED (LOT UNK) WAS REPORTED TO HAVE THE CARTRIDGE HOLDER BROKEN. THE DEVICE WAS RETURNED TO THE MFR ON (B)(6) 2009, AND THE ENGAGEMENT TABS WERE FOUND TO BE BROKEN. THIS HUMAPEN ERGO BURGUNDY/CLEAR PEN BODY WITH A CLEAR CARTRIDGE HOLDER ATTACHED IS ASSOCIATED WITH PRODUCT COMPLAINT NUMBER (B)(4). THE OPERATOR DEVICE WAS UNK. IT WAS UNK IF THE OPERATOR WAS TRAINED TO USE IT. THE PT INFORMED THAT USE HUMAPEN FOR APPROX FOUR YEARS BUT IT WAS UNK FOR HOW LONG SHE USED THIS MODEL. UPDATE (B)(6) 2009. PER INTERNAL REVIEW ON (B)(6) 2009, THE NARRATIVE INFO WAS UPDATED ABOUT INDICATION THAT CIRM WAS IDENTIFIED AFTER THE DEVICE WAS RETURNED. ADDED LOT OF HUMAPEN BURGUNDY/CLEAR PEN BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMAPEN ERGO BURGUNDY/CLEAR/CLEAR CH PEN INJECTOR FOR TREATMENT PURPOSES FMF ELI LILLY AND CO. MS8930 0603A04

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK