BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM ONE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 12927272 · Received December 3, 2021

    Report

    Report Number
    3004753838-2021-305824
    Event Type
    Malfunction
    Date Received
    December 3, 2021
    Date of Event
    November 17, 2021
    Report Date
    December 3, 2021
    Manufacturer
    DEXCOM, INC.
    Product Code
    PJT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SIGNAL LOSS OVER ONE HOUR OCCURRED. IT WAS DETERMINED THAT LOSS OF CONNECTION WAS RELATED TO THE MOBILE APPLICATION. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. 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
    1820038 DEXCOM ONE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR PJT DEXCOM, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Female