BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 22480745 · Received July 11, 2025

    Report

    Report Number
    3004753838-2025-180345
    Event Type
    Injury
    Date Received
    July 11, 2025
    Date of Event
    June 17, 2025
    Report Date
    July 11, 2025
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270003935
    PMA / PMN Number
    K213919
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

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

    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 WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT STARTED GETTING BLURRY VISION AND WAS NOT ABLE TO CHECK THE READINGS ON THE CGM. A FAMILY MEMBER TOOK THE PATIENT TO THE EMERGENCY ROOM. AT THE ER A BG WAS TAKEN AND IT WAS 351 MG/DL WHILE THE CGN WAS 130 MG/DL. THE PATIENT WAS TREATED WITH 2 LITERS OF IV FLUIDS OF SODIUM CHLORIDE AND HAD AN EYE EXAM. SCANS WERE DONE TO ENSURE HER VISION WOULD RETURN TO NORMAL. SHE WAS IN THE ER FOR 6 HOURS UNTIL HER BLOOD SUGAR STABILIZED. AT THE TIME OF THE REPORT, THE PATIENT WAS DOING FINE. 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 FALLS 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
    873742 DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9500-161 1725056002 00386270003935

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female Other INSULIN PUMP.