BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIVONGO LANCET

    MDR report key: 15571822 · Received October 10, 2022

    Report

    Report Number
    3011196194-2022-00020
    Event Type
    Injury
    Date Received
    October 10, 2022
    Date of Event
    August 18, 2022
    Report Date
    October 6, 2022
    Manufacturer
    LIVONGO HEALTH INC
    Product Code
    QRK
    PMA / PMN Number
    K133584
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    PATIENT REPORTS RECEIVING AN INFECTION AND BRUISED FINGERS DUE TO THE LIVONGO LANCING DEVICE AND LANCETS. THE PATIENT WENT TO THE DOCTOR AND WAS INFORMED TO STOP USING THE LANCING DEVICE DUE TO THE LANCETS. THE PATIENT ALSO REPORTED THAT SOME OF THEIR LANCETS WERE DULL AND A FEW WERE MISSING A NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236932 LIVONGO LANCET LANCET QRK LIVONGO HEALTH INC 2011016

    Patients

    Seq Age Sex Outcome Treatment
    1 85 DA Unknown Other