BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIVONGO BLOOD GLUCOSE METER

    MDR report key: 18759195 · Received February 22, 2024

    Report

    Report Number
    3011196194-2024-00012
    Event Type
    Injury
    Date Received
    February 22, 2024
    Date of Event
    December 19, 2023
    Report Date
    February 22, 2024
    Manufacturer
    TELADOC HEALTH INC
    Product Code
    NBW
    PMA / PMN Number
    K133584
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR THIS INVETSIGATION. SHOULD THE DEVICE BE RETURNED AT A LATER DATE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    THE PATIENT INITIALLY CONTACTED TELADOC HEALTH REGARDING CONCERNS WITH THE ACCURACY OF THEIR LIVONGO METER ON 12/19/2023. ADDITIONAL REACH OUT WAS MADE TO UNDERSTAND THE ISSUE, AND IT WAS DISCOVERED ON 1/23/2024 THAT ON 12/19/2023, THE PATIENT USED THEIR METER AND RECEIVED A READING THAT WAS HIGH RESULTING IN THE PATIENT TAKING TOO MUCH INSULIN DUE. THE PATIENT STATED THAT THEY SOUGHT MEDICAL ATTENTION AT A HOSPITAL FOR THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89989 LIVONGO BLOOD GLUCOSE METER BLOOD GLUCOSE METER NBW TELADOC HEALTH INC BG300C

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Other