BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FITBIT

    MDR report key: 23866353 · Received December 22, 2025

    Report

    Report Number
    MW5180945
    Event Type
    Malfunction
    Date Received
    December 22, 2025
    Date of Event
    December 15, 2025
    Report Date
    December 16, 2025
    Manufacturer
    FITBIT LLC
    Product Code
    QDA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    SO, WEARING A GOOGLE PIXEL WATCH 4 I MEASURED MY HR. THE DEVICE SYNCED WITH MY GOOGLE PIXEL 10 PRO'S FITBIT. THE PROBLEM IS THE DIFFERENCE IN THE VALUES THEY DISPLAY. ON THE PHONE, WHICH IS MOST PROBABLY MORE CORRECT: 52-161 BPM ON FITBIT: 51-204 BPM THEN TODAY THE SAME AGAIN. IT MAKES ABSOLUTELY NO SENSE THAT BOTH DO NOT SHOW THE SAME. THE PROBLEM IS MOST LIKELY THAT FITBIT (A GOOGLE PRODUCT) AND THE PIXEL WATCH USE DIFFERENT ALGORITHMS OR THERE IS A SYNCING ISSUE, WHICH I FIND HARD TO IMAGINE. THIS HAPPENS A LOT, THOUGH SELDOM THIS DRASTICALLY. GIVEN THESE ARE FDA CERTIFIED DEVICES, I WAS WONDERING WHAT YOU THINK REGARDING IT. I REPORTED IT TO GOOGLE TOO, THEY MADE ME JUMP THROUGH ALL THE HOOPS LIKE REINSTALLING THE FITBIT APP, WHICH RESULTED IN NO CHANGE. I AM UPLOADING THE SCREENSHOTS BELOW. PT-4582. DEVICE-2588. REFERENCED REPORTS-MW5180944.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2507986 FITBIT ELECTROCARDIOGRAPH SOFTWARE FOR OVER-THE-COUNTER USE QDA FITBIT LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Male