BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMAPEN ERGO, TEAL/CLEAR

    MDR report key: 500413 · Received November 26, 2003

    Report

    Report Number
    1819470-2003-00042
    Event Type
    Malfunction
    Date Received
    November 26, 2003
    Report Date
    November 1, 2003
    Manufacturer
    ELI LILLY AND CO.
    Product Code
    FMF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    THE PT WAS TAKING AN UNSPECIFIED MEDICATION VIA A HUMAPEN ERGO TEAL/CLEAR PEN BODY (LOT 40237) FOR AN UNK INDICATION. IT WAS UNK WHO OPERATED THE DEVICE OR IF IT WAS UNK WHO OPERATED THE DEVICE OR IF THE OPERATER OF THE DEVICE WAS TRAINED. IT WAS REPORTED THAT THE INJECTION SCREW DID NOT WORK. THE DEVICE WAS RETURNED TO THE COMPANY. INITIAL ANALYSIS BY PDS FOUND: TWO BROKEN ENGAGEMENT TABS. THE PRODUCT IS OUT OF SPECIFICATION FOR DOSE ACCURACY. TWO TAB BREAKAGE HAS BEEN SHOWN TO DELIVER AN UNDER DOSE OF INSULIN. THE DEVICE IS BEING FORWARDED FOR AN ENGINEERING INVESTIGATION FOR ADDITIONAL EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMAPEN ERGO, TEAL/CLEAR PEN INJECTOR FMF ELI LILLY AND CO. MS8929 40237

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO