BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIVONGO BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 12804230 · Received November 10, 2021

    Report

    Report Number
    MW5105278
    Event Type
    Malfunction
    Date Received
    November 10, 2021
    Date of Event
    November 8, 2021
    Report Date
    November 9, 2021
    Manufacturer
    LIVONGO HEALTH
    Product Code
    CGA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    A FEW MONTHS AGO I STARTED USING THE LIVONGO BLOOD GLUCOSE MONITORING SYSTEM TO HELP MANAGE MY TYPE II DIABETES. A WEEK AGO, I STARTED A TWO WEEK TRIAL USING THE FREESTYLE LIBRE 2 FLASH GLUCOSE MONITORING SYSTEM. WHEN I COMPARED THE READINGS FROM THE TWO, THE LIBRE WAS CONSISTENTLY MEASURING 40-50 MG/DL HIGHER THAN THE LIVONGO. I KNOW THE READINGS VARY SOME BASED ON THE DIFFERENT TECHNIQUE USED TO MEASURE VALUE. SINCE THE AVERAGE VALUE OF THE LIBRE CORRESPONDS TO THE APPROXIMATE A1C FROM MY LAST BLOOD TEST, I SUSPECTED THE LIVONGO WAS INCORRECT. I STILL HAD MY OLD ONETOUCH ULTRA 2 MONITOR. WHEN I USED IT, THE VALUE WAS CONSISTENT WITH THE LIBRE. THREE EXAMPLES I MEASURED WERE: YESTERDAY BEFORE LUNCH: LIVONGO 77, LIBRE 115, ONETOUCH 131 YESTERDAY BEFORE DINNER: LIVONGO 149, LIBRE 193, ONETOUCH 209 THIS MORNING BEFORE BREAKFAST: LIVONGO 105, LIBRE 152, ONETOUCH 150 FIRST TWO READINGS, THE LIBRE WAS SHOWING A DOWNWARD TREND WHICH IS CONSISTENT WITH THE ONETOUCH BEING SLIGHTLY HIGHER. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1683298 LIVONGO BLOOD GLUCOSE MONITORING SYSTEM GLUCOSE OXIDASE, GLUCOSE CGA LIVONGO HEALTH BG300

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Other