BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIVONGO

    MDR report key: 10436765 · Received August 20, 2020

    Report

    Report Number
    MW5096181
    Event Type
    Malfunction
    Date Received
    August 20, 2020
    Date of Event
    April 25, 2020
    Report Date
    August 19, 2020
    Manufacturer
    LIVONGO HEALTH
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I BECAME A MEMBER OF LIVONGO EARLIER THIS YEAR (2020) AFTER THEY KEPT ON SENDING ME MAIL POST CARDS TO TRY THEIR MEMBERSHIP FOR BLOOD GLUCOSE MONITORING . I WAS USING ONE TOUCH BEFORE . I HAVE BEEN CHECKING MY BLOOD SUGAR FOR THE PAST FOUR YEARS AND KNOW WHAT MY NORMAL RANGE IS. AFTER SWITCHING TO LIVONGO FOR A WEEK, I FOUND OUT THAT MY BLOOD SUGAR WAS BELOW MY NORMAL LEVELS AND I WAS NO LONGER IN THE PRE-DIABETIC RANGE. I CONFIRMED IT WITH MY ONE TOUCH METER AND ALSO FREESTYLE METER. ONE TOUCH AND FREE STYLE WAS IN ONE POINTS RANGE OF EACH OTHER WHILE LIVONGO WAS 20-25 POINTS APART. I KEPT ON COMPARING AND THEN I CONTACTED LIVONGO ABOUT THEIR PRODUCT INACCURACY. THEY SENT ME A NEW METER AND NEW TEST STRIPS. THE READING WAS AGAIN OFF BY 25 POINTS. I CALLED THEM AND TOLD THEM THAT THEIR PRODUCT IS FAULTY AND THEY TOLD ME THAT THEY ARE FDA APPROVED. REALLY, IS THAT IT? FDA IS THEIR GO TO REFUGE WHEN QUESTIONED ABOUT THE AUTHENTICITY OF THEIR PRODUCT. I STOPPED USING THEIR PRODUCT AND THEY STARTED EMAILING ME THAT I HAVE NOT CHECKED MY BLOOD GLUCOSE FOR THREE MONTHS AND THEY WILL CANCEL MY MEMBERSHIP. I STARTED USING IT AGAIN BUT THE PROBLEM CONTINUES. ONE DAY, I GOT A CALL FROM LIVONGO AT 11PM AT NIGHT SAYING THAT MY BLOOD SUGAR IS 49 AND IT IS ABNORMAL AND I TOLD THE REPRESENTATIVE THAT LIVONGO IS FAULTY AND I SENT THEM THE PICTURE OF ONE TOUCH SHOWING MY GLUCOSE AT OVER 120 POINTS. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899561 LIVONGO SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER NBW LIVONGO HEALTH BLOOD GLUCOSE MONITOR
    899562 LIVONGO SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER NBW LIVONGO HEALTH

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR