BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIVONGO

    MDR report key: 10540678 · Received September 15, 2020

    Report

    Report Number
    MW5096665
    Event Type
    Malfunction
    Date Received
    September 15, 2020
    Date of Event
    August 13, 2020
    Report Date
    September 13, 2020
    Manufacturer
    LIVONGO HEALTH
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    GLUCOSE METER PROBLEMS; I GOT A FREE METER FROM (B)(6) FROM LIVONGO. I HAD BEEN USING A ONE TOUCH VERIO FLEX. WHEN TESTING AT THE SAME TIME DURING TRANSITION, I NOTICED THAT SOMETIMES THE LIVONGO READING COULD BE AS MUCH AS 20 TO 30 POINTS HIGHER THAN THE VERIO. I CAN PROVIDE MANY INSTANCES BUT IN GENERAL THE RESULTS VARY IN A RANGE FROM 10 TO 30 POINTS. I CONTACTED (B)(6). THEY ADVISED THAT THEY ARE AWARE OF THIS PROBLEM AND ARE ADDRESSING IT. IT WAS DICE WHO ADVISED THAT I SEND IN THIS INFORMATION. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    999818 LIVONGO SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER NBW LIVONGO HEALTH

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other