BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIVONGO BLOOD GLUCOSE METER CHARGER

    MDR report key: 16280646 · Received February 1, 2023

    Report

    Report Number
    3011196194-2023-00007
    Event Type
    Malfunction
    Date Received
    February 1, 2023
    Date of Event
    January 10, 2023
    Report Date
    January 30, 2023
    Manufacturer
    LIVONGO HEALTH, INC
    Product Code
    NBW
    PMA / PMN Number
    K133584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT NO LONGER HAS THE DEVICE. THE PATIENT REPORTED SMELLING SMOKE AND STATED BURN MARKS WERE AROUND THE CHARGING PORT.

    Description of Event or Problem · 0

    PATIENT CONNECTED THE CHARGER TO THEIR BLOOD GLUCOSE METER, REPORTED A SMOKY SMELL AND STATED BURN MARKS APPEARED AROUND THE CHARGING PORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1301499 LIVONGO BLOOD GLUCOSE METER CHARGER CHARGER NBW LIVONGO HEALTH, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Unknown