BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 20273119 · Received September 20, 2024

    Report

    Report Number
    3004753838-2024-242121
    Event Type
    Injury
    Date Received
    September 20, 2024
    Date of Event
    August 28, 2024
    Report Date
    September 20, 2024
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    DEN170088
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). H6 CODES: HEALTH EFFECT - CLINICAL CODE: E014302 (DECREASED LEVEL OF CONSCIOUSNESS).

    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 ARM, WHICH IS OFF-LABEL USAGE OF THE DEVICE. ON 08/29/2024, THE PATIENT'S PARENT REPORTED THE PATIENT EXPERIENCED A CGM ACCURACY ISSUE WHICH OCCURRED ON AN UNSPECIFIED DAY AFTER THE SENSOR WAS INSERTED INTO THE ARM. ON (B)(6) 2024, THE PATIENT WAS AT VOLLEYBALL PRACTICE WHEN SHE BEGAN NOT FEELING WELL. SHE WAS WEAK AND "NOT RESPONDING WELL". THE PATIENT'S CGM WAS READING 120 MG/DL, AND THE BG METER WAS READING 31 MG/DL. THE PATIENT'S COACH PROVIDED THE PATIENT WITH "SUGAR DRINKS" AND M&M CANDIES. THE PATIENT RECOVERED AFTER TREATMENT AND DID NOT SEEK ANY TREATMENT FROM A HIGHER LEVEL OF CARE. THE PATIENT WAS IN GOOD CONDITION AT THE TIME OF REPORT. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. THE REPORTED GLUCOSE VALUES FALL WITHIN THE D ZONE OF THE PARKES ERROR GRID. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1309533 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Female