BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIVONGO BLOOD GLUCOSE METER

    MDR report key: 11211144 · Received January 21, 2021

    Report

    Report Number
    3011196194-2021-00002
    Event Type
    Injury
    Date Received
    January 21, 2021
    Date of Event
    October 29, 2020
    Report Date
    January 21, 2021
    Manufacturer
    LIVONGO HEALTH INC
    Product Code
    NBW
    PMA / PMN Number
    K133584
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT REPORTS THAT SHE HAD ADMINISTERED INSULIN BASED ON WHAT SHE WAS GOING TO EAT IN THE FUTURE, THE AMOUNT OF INSULIN TAKEN IS UNKNOWN, AND THE AMOUNT OF FOOD CONSUMED IS ALSO UNKNOWN. THE AMOUNT OF TIME BETWEEN ADMINISTERING INSULIN, EATING, AND LATER TESTING BLOOD GLUCOSE USING THE LIVONGO METER 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 RECEIVED A BLOOD GLUCOSE READING OF 121 WHEN USING THE LIVONGO METER. THE PATIENT REPORTED THAT WHEN SHE STOOD UP, SHE PASSED OUT. THE PATIENT CALLED EMS AND THEIR METER SHOWED A READING OF 65. EMS ADMINISTERED GLUCOSE. IT IS UNKNOWN HOW MUCH TIME PASSED BETWEEN THE READING OF 121 ON THE LIVONGO METER AND THE 65 FROM THE EMS METER. THE PATIENT WAS SENT A REPLACEMENT BLOOD GLUCOSE METER AND TEST STRIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103199 LIVONGO BLOOD GLUCOSE METER BLOOD GLUCOSE METER NBW LIVONGO HEALTH INC BG300C

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention