BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIVONGO BLOOD GLUCOSE METER / TEST STRIPS

    MDR report key: 9823609 · Received March 11, 2020

    Report

    Report Number
    MW5093690
    Event Type
    Malfunction
    Date Received
    March 11, 2020
    Date of Event
    March 9, 2020
    Report Date
    March 9, 2020
    Manufacturer
    LIVONGO HEALTH
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    INACCURATE METER READINGS; LIVONGO BLOOD GLUCOSE PRODUCT. I BELIEVE THIS BLOOD GLUCOSE PRODUCT IS VERY INACCURATE BECAUSE I TESTED EACH COLOR OF TEST STRIPS AT ONE TIME AND FOUND A 12-16 POINT DIFFERENCE BETWEEN THE COLORS AS FOLLOWS: BLUE 134, GRAY 134, PURPLE 146, TURQUOISE 146, GREEN 130. I GOT THE PRODUCT FREE THROUGH MY HEALTH INSURANCE UNTIL IT STOPPED WHEN THE INSURANCE CHANGED. I AM NOT UPSET ABOUT LOSING THE FREE SUPPORT, BUT THE TESTS WERE ALWAYS HIGHER THAN MY PREVIOUS METER AND TEST STRIPS. THIS MAY IMPACT USERS WHO RELY ON ACCURATE READINGS. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283628 LIVONGO BLOOD GLUCOSE METER / TEST STRIPS SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER NBW LIVONGO HEALTH BG300

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other