BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 GLUCOSE PROGRAM CONTINUOUS GLUCOSE MONITORING (CGM) SYSTEM

    MDR report key: 13048610 · Received December 20, 2021

    Report

    Report Number
    3004753838-2021-431072
    Event Type
    Malfunction
    Date Received
    December 20, 2021
    Date of Event
    November 22, 2021
    Report Date
    December 20, 2021
    Manufacturer
    DEXCOM, INC.
    Product Code
    QDK
    PMA / PMN Number
    K203089
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE SENSOR WAS INSERTED INTO THE ABDOMEN ON (B)(6) 2021. DATA WAS EVALUATED AND THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THE REPORTED GLUCOSE VALUES FALL WITHIN THE C ZONE OF THE PARKES ERROR GRID. THE DATA INVESTIGATION FOUND A DIFFERENCE IN VALUES THAT FALL WITHIN THE D ZONE OF THE PARKES ERROR GRID. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1947016 DEXCOM G6 GLUCOSE PROGRAM CONTINUOUS GLUCOSE MONITORING (CGM) SYSTEM CONTINUOUS GLUCOSE MONITOR QDK DEXCOM, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female