BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMALOG 75/25 KWIKPEN

    MDR report key: 6040130 · Received October 7, 2016

    Report

    Report Number
    MW5065496
    Event Type
    Malfunction
    Date Received
    October 7, 2016
    Date of Event
    October 6, 2016
    Report Date
    October 6, 2016
    Manufacturer
    ELI LILLY
    Product Code
    FMF
    UDI-DI
    00002879701
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT WAS UNABLE TO INJECT INSULIN AFTER DIALING PEN; PEN NEEDLE WAS UNABLE TO PUNCTURE SEAL; TRIED SEVERAL TIMES. PT TRIED W/O NEEDLE AND BURST SEAL. DOSE OR AMOUNT: 50 UNITS. FREQUENCY: BID. ROUTE: SUB-Q. IS THE PRODUCT COMPOUNDED?: NO. IS THE PRODUCT OVER-THE-COUNTER?: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664111 HUMALOG 75/25 KWIKPEN SYRINGE PEN FMF ELI LILLY C506933E 00002879701

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR