BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTINUOUS GLUCOSE MONITOR

    MDR report key: 12375383 · Received August 26, 2021

    Report

    Report Number
    3004753838-2021-147674
    Event Type
    Malfunction
    Date Received
    August 26, 2021
    Date of Event
    August 6, 2021
    Report Date
    August 26, 2021
    Manufacturer
    DEXCOM, INC.
    Product Code
    PJT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SIGNAL LOSS OVER ONE HOUR OCCURRED. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF 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
    1273112 CONTINUOUS GLUCOSE MONITOR PJT DEXCOM, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR