BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FITBIT SENSE 2

    MDR report key: 21197279 · Received January 21, 2025

    Report

    Report Number
    MW5164935
    Event Type
    Malfunction
    Date Received
    January 21, 2025
    Date of Event
    January 10, 2025
    Report Date
    January 14, 2025
    Manufacturer
    FITBIT LLC/GOOGLE
    Product Code
    QDB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    FITBIT SENSE 2 IS SOLD AS "FDA CLEARED. OUR AFIB TECHNOLOGIES HAVE BEEN FDA CLEARED." HOWEVER, FOR MANY USERS INCLUDING ME, THE ECG (ELECTROCARDIOGRAM) CANNOT BE DOWNLOADED OR SHARED DUE TO A BUG. GOOGLE/FITBIT ARE AWARE OF THE BUG: HTTPS://COMMUNITY.FITBIT.COM/T5/SENSE-2/UNABLE-TO-DOWNLOAD-SENSE-2-ECG-REPORTS/M-P/5697360 CONSUMERS ARE PURCHASING THE FITBIT SENSE 2 BECAUSE IT ADVERTISED AS FDA CLEARED BUT MANY CANNOT USE THE DEVICE FOR IT'S ADVERTISED FEATURE. UNABLE TO RETRIEVE RESULTS OF ECG FROM FITBIT SENSE 2 DUE TO SOFTWARE BUG KNOWN TO GOOGLE/FITBIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722291 FITBIT SENSE 2 PHOTOPLETHYSMOGRAPH ANALYSIS SOFTWARE FOR OVER-THE-COUNTER USE QDB FITBIT LLC/GOOGLE

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Other