BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIVONGO MODEL BG300 BLOOD GLUCOSE METER

    MDR report key: 11982749 · Received June 10, 2021

    Report

    Report Number
    MW5101821
    Event Type
    Malfunction
    Date Received
    June 10, 2021
    Date of Event
    June 5, 2021
    Report Date
    June 8, 2021
    Manufacturer
    LIVONGO HEALTH
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    FALSE HIGH BLOOD GLUCOSE; LIVONGO BLOOD GLUCOSE METER REPORTED 341 MG/DL AT 12:48 PM. REPEAT TEST USING ONETOUCH METER: 180MG/DL AT 12:49 PM. REPEAT TEST USING LIVONGO METER AT 12:50 PM WAS 187MG/DL. REPORTED RESULTS TO LIVONGO BUT THEIR TECH. SUPPORT TEAM WAS UNAVAILABLE AND THEY FAILED TO PROVIDE A PROMISED FOLLOW-UP CALL TO REVIEW DETAILS. THIS WAS THE 2ND RECENT EPISODE OF INEXPLICABLY HIGH READINGS USING THE LIVONGO METER. CAREFUL HANDWASHING PROCEDURES RULED OUT TEST STRIP CONTAMINATION DURING TESTING. I AM A PHYSICIAN WITH OVER 50 YEARS EXPERIENCE AND WAS A MEMBER OF MANAGEMENT STAFF OF FDA CBER FOR 10 YEARS IN SO PAST SO TAKE ADVERSE EVENT REPORTING AND FOLLOW-UP SERIOUSLY, SO HAVE A MAJOR CONCERN WITH A COMPANY THAT FAILS TO FOLLOW UP REPORTS THOROUGHLY. SINCE I HAVE NO FOLLOW-UP FROM LIVONGO, I CANNOT KNOW HOW (OR WHETHER) THEY'VE INVESTIGATED THIS ISSUE BUT IT SEEMS UNLIKELY THAT SUCH MEASUREMENT ERRORS WERE ISOLATED INCIDENTS. ALL OF THE TEST STRIPS WERE FROM THE SAME LOT BUT ONLY 2 GAVE ABERRANT HIGH READINGS. HOWEVER, THE RESULTS DO RAISE QUESTIONS ABOUT OVERALL ACCURACY OF THE SYSTEM UNLESS MORE DATA CAN BE PROVIDED. THIS TEST SYSTEM IS RECOMMENDED & SUPPORTED BY BLUE-CROSS/BLUE-SHIELD SO IS QUITE WIDELY USED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    874965 LIVONGO MODEL BG300 BLOOD GLUCOSE METER SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER NBW LIVONGO HEALTH
    874966 FIRMWARE 2.4.1/TESTSTRIP SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER NBW LIVONGO HEALTH BG300 891329 00853553005288

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other