BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 23018139 · Received September 10, 2025

    Report

    Report Number
    3004753838-2025-253308
    Event Type
    Injury
    Date Received
    September 10, 2025
    Date of Event
    July 30, 2025
    Report Date
    September 10, 2025
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270003935
    PMA / PMN Number
    K213919
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPERGLYCEMIA. H6 HEALTH EFFECT - IMPACT CODE - F18 REHABILITATION. H6 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 WEARABLE WAS INSERTED INTO THE ABDOMEN, WHICH IS OFF-LABEL USAGE OF THE DEVICE ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT¿S CGM WAS READING 345 MG/DL. NO BG METER COMPARISON VALUE WAS REPORTED. THE PATIENT WAS FEELING WEAK AND LIGHTHEADED. HE LEANED AGAINST THE WALL AND ¿NEARLY LOST CONSCIOUSNESS¿. THE PATIENT¿S WIFE CALLED EMERGENCY MEDICAL SERVICES (EMS). ONCE EMS ARRIVED, THE PATIENT¿S BG METER READING WAS 449 MG/DL AND THE PATIENT MOBILE APP HAD ¿TURNED OFF¿ AND THE PATIENT¿S CGM READING WAS NOT KNOWN AT THIS TIME. THE PATIENT WAS TRANSPORTED TO THE EMERGENCY ROOM (ER). AT THE ER, THE PATIENT WAS TREATED WITH INSULIN AND OTHER UNSPECIFIED MEDICATIONS. THE PATIENT WAS THEN TRANSFERRED TO A COMMUNITY REHAB CENTER. THE PATIENT WAS AT THE REHAB CENTER FOR NINE DAYS AND WAS DISCHARGED ON (B)(6) 2025. THE PATIENT WAS ¿STABLE¿ AT THE TIME OF REPORT. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND THE PROBABLE CAUSE COULD NOT BE DETERMINED. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1750249 DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9500-161 1825137003 00386270003935

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Male Other INSULIN PEN.