BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIVONGO BLOOD GLUCOSE METER

    MDR report key: 12701098 · Received October 26, 2021

    Report

    Report Number
    3011196194-2021-00017
    Event Type
    Injury
    Date Received
    October 26, 2021
    Date of Event
    September 30, 2021
    Report Date
    October 18, 2021
    Manufacturer
    LIVONGO 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT REPORTS THAT SHE HAD MEDICATED HERSELF BASED ON THE LIVONGO METER'S RESULTS AND CONSEQUENTLY NEEDED TO CALL EMS. THE AMOUNT OF MEDICATION TAKEN IS UNKNOWN, AND ANY INTERVENTION FROM EMS IS ALSO UNKNOWN. THE BG METER HAS NOT BEEN RETURNED TO THE MANUFACTURER. SHOULD THE DEVICE BE RETURNED, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE RESULTS OF THE TESTING.

    Description of Event or Problem · 1

    THE PATIENT REPORTED A COMPLAINT THAT THEIR LIVONGO METER WAS NOT ACCURATE. THE PATIENT MEDICATED HERSELF AND AFTERWARD HAD TO CALLED EMS. IT IS UNKNOWN WHAT MEDICATION THE PATIENT TOOK OR IF ANY INTERVENTION PEFORMED BY THE EMS. THE PATIENT WAS SENT A REPLACEMENT BLOOD GLUCOSE METER AND TEST STRIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1598913 LIVONGO BLOOD GLUCOSE METER BLOOD GLUCOSE METER NBW LIVONGO HEALTH INC BG300C

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention