BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTINUOUS GLUCOSE MONITOR

    MDR report key: 13002575 · Received December 14, 2021

    Report

    Report Number
    3004753838-2021-312665
    Event Type
    Malfunction
    Date Received
    December 14, 2021
    Date of Event
    November 27, 2021
    Report Date
    December 14, 2021
    Manufacturer
    DEXCOM, INC.
    Product Code
    PJT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN APP CRASH ALERT OCCURRED. NO DATA OR PRODUCT 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
    1905026 CONTINUOUS GLUCOSE MONITOR PJT DEXCOM, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Female