BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM FOLLOW APP

    MDR report key: 13125643 · Received December 31, 2021

    Report

    Report Number
    3004753838-2021-436990
    Event Type
    Malfunction
    Date Received
    December 31, 2021
    Date of Event
    November 6, 2020
    Report Date
    December 31, 2021
    Manufacturer
    DEXCOM, INC.
    Product Code
    PJT
    UDI-DI
    00386270000804
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT MOBILE APP INTERRUPTION DUE TO OS UPGRADE ON SMART DEVICE OCCURRED. DATA WAS RECEIVED BUT NOT INVESTIGATED AS DATA WILL NOT CONFIRM THE ISSUE. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2032713 DEXCOM FOLLOW APP CONTINUOUS GLUCOSE MONITOR PJT DEXCOM, INC. NA 00386270000804

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male