BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 23824410 · Received December 16, 2025

    Report

    Report Number
    3004753838-2025-343648
    Event Type
    Injury
    Date Received
    December 16, 2025
    Date of Event
    December 5, 2025
    Report Date
    December 16, 2025
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270003089
    PMA / PMN Number
    DEN170088
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA.

    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. ACCORDING TO THE PATIENT¿S HEALTHCARE PROVIDER, ON (B)(6) 2025, THE PATIENT WAS BROUGHT TO THE HOSPITAL BY AMBULANCE WITH HYPOGLYCEMIA AND COMA WHILE UNDERGOING THERAPY WITH THEIR DIABELOOP INSULIN PUMP IN CLOSED-LOOP MODE. AT THE TIME OF THE REPORT THE PATIENT WAS FINE. EXACT VALUES WERE NOT REPORTED, THE REPORTER STATES THAT THE PATIENT¿S BLOOD GLUCOSE VALUES WERE BETWEEN 12 AND 50 MG/DL, WHILE THE SENSOR SHOWED VALUES ABOVE 100 MG/DL WITHOUT ANY DOWNWARD TREND. THERE WAS NO INFORMATION PROVIDED ABOUT THE MEDICAL INTERVENTION NOR THE TREATMENT. DEXCOM TECHNICAL SUPPORT ATTEMPTED TO FOLLOW UP WITH THE PATIENT MULTIPLE TIMES TO OBTAIN FURTHER DETAILS AND CLARIFICATION REGARDING THE INCIDENT, BUT THEY WERE UNABLE TO MAKE CONTACT. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND THE PROBABLE CAUSE COULD NOT BE DETERMINED. THE REPORTED GLUCOSE VALUES FALL WITHIN THE C 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
    2038773 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. NI NI 00386270003089

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Female Other DIABELOOP ROCHE ACCUCHECK INSIGHT