BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 23584048 · Received November 18, 2025

    Report

    Report Number
    3004753838-2025-322240
    Event Type
    Injury
    Date Received
    November 18, 2025
    Date of Event
    November 7, 2025
    Report Date
    November 18, 2025
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270004109
    PMA / PMN Number
    K213919
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA. H6 HEALTH EFFECT - CLINICAL CODE - E014302 DECREASED LEVEL OF CONSCIOUSNESS. H6 MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A WEARABLE FAILURE OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON (B)(6). 2025, THE PATIENT WAS SITTING ON THE COUCH WATCHING TV WHEN HE ¿ALMOST PASSED OUT¿. THE PATIENT¿S WIFE CAME HOME AND FOUND THE PATIENT BARELY CONSCIOUS. THE PATIENT'S CGM WAS SHOWING A MESSAGE TO ¿REPLACE SENSOR¿, THEREFORE, NO CGM VALUES WERE BEING PROVIDED TO THE PATIENT. IT WAS NOT SPECIFIED WHEN THE PATIENT BECAME AWARE OF THE WEARABLE FAILURE. THE PATIENT¿S WIFE TREATED THE PATIENT WITH SUGAR AND A BOTTLE OF COKE. IT TOOK APPROXIMATELY 30 MINUTES FOR THE PATIENT¿S GLUCOSE LEVEL TO IMPROVE. NO BG METER VALUES WERE REPORTED DURING THIS EVENT. THE PATIENT DID NOT SEEK ANY ASSISTANCE FROM A HIGHER LEVEL OF CARE. THE PATIENT WAS FEELING WEAK AFTER THE EVENT. THE PATIENT WAS ¿FINE¿ AT THE TIME OF REPORT. PERFORMANCE DATA WAS REVIEWED. THE ALLEGATION WAS NOT CONFIRMED VIA DATA. THE PROBABLE CAUSE COULD NOT BE DETERMINED POST INVESTIGATION AS THE ALLEGATION WAS NOT FOUND. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2236490 DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9500-161 1825059008 00386270004109

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Other