BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 25152600 · Received May 12, 2026

    Report

    Report Number
    3004753838-2026-149779
    Event Type
    Injury
    Date Received
    May 12, 2026
    Date of Event
    January 27, 2026
    Report Date
    May 12, 2026
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270001863
    PMA / PMN Number
    K213919
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). (B)(6). HEALTH CANADA FILE #241443. DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS.

    Description of Event or Problem · 0

    A HEALTH CANADA/MEDWATCH REPORT WAS RECEIVED ON 04/30/2026. IT WAS REPORTED THAT AN ALERT/NOTIFICATION SETTINGS OCCURRED. THE DATE OF THE EVENT IS AN APPROXIMATION. ACCORDING TO AN EMAIL REPORT, ON OR AROUND 01/27/2026, THE PATIENT REPORTEDLY EXPERIENCED HYPOGLYCEMIA WHILE SLEEPING, FOLLOWED BY A SIGNAL LOSS. THE ALERT SYSTEM DID NOT NOTIFY THE PATIENT OF THE HYPOGLYCEMIC EVENT, NOR DID IT ALARM WHEN THE SIGNAL WAS LOST. THE PATIENT¿S PARTNER SUBSEQUENTLY FOUND THE PATIENT UNCONSCIOUS ON THE FLOOR. UPON ACCESSING THE PATIENT¿S PHONE, THE PARTNER OBSERVED THAT THE CGM SIGNAL HAD BEEN LOST AND THAT PRIOR GLUCOSE READINGS WERE TRENDING DOWNWARD TOWARD 3.0 MMOL/L. THERE WAS NO TREATMENT DOCUMENTED FOR THIS EVENT. AT THE TIME OF THE REPORT, THE PATIENT WAS REPORTED TO BE DOING WELL. ALTHOUGH ATTEMPTS TO FOLLOW UP WITH THE PATIENT FOR ADDITIONAL EVENT DETAILS WERE MADE, CONTACT WAS UNSUCCESSFUL. PERFORMANCE DATA WAS REVIEWED. DATA INVESTIGATION COULD NOT CONFIRM AN ALERT/NOTIFICATION SETTINGS ISSUE. DATA WAS PROVIDED FOR INVESTIGATION. CONFIRMATION OF THE COMPLAINT WAS UNDETERMINED VIA DATA. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519337 DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 00386270001863

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female Other