BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 22066104 · Received May 21, 2025

    Report

    Report Number
    3004753838-2025-126031
    Event Type
    Injury
    Date Received
    May 21, 2025
    Date of Event
    July 22, 2024
    Report Date
    May 21, 2025
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270002518
    PMA / PMN Number
    K213919
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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 ALERT/NOTIFICATION SETTINGS ISSUE OCCURRED. DATE OF EVENT IS AN APPROXIMATION. ACCORDING TO A REPORT RECEIVED ON MAY 9, 2025, VIA EMAIL FROM A UNITED STATES DEPARTMENT OF VETERANS AFFAIRS (VA) HEALTHCARE PROVIDER (HCP), THE PATIENT EXPERIENCED A HYPOGLYCEMIC EVENT IN (B)(6) 2024. DURING THIS EVENT, THE PATIENT¿S BLOOD GLUCOSE LEVEL DROPPED TO 40 MG/DL. IT WAS NOTED THAT THE PATIENT DID NOT RESPOND TO THE DEXCOM ALARM FROM AN UNSPECIFIED DISPLAY DEVICE AND SUBSEQUENTLY REQUIRED EMERGENCY MEDICAL ASSISTANCE, INCLUDING AMBULANCE TRANSPORT TO THE HOSPITAL. NO ADDITIONAL DETAILS REGARDING THE INCIDENT WERE PROVIDED IN THE REPORT. MULTIPLE ATTEMPTS TO FOLLOW UP WITH THE REPORTER FOR FURTHER INFORMATION WERE UNSUCCESSFUL. NO PRODUCT OR DATA WAS PROVIDED FOR INVESTIGATION. THE ALLEGATION AND PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645501 DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. NI NI 00386270002518

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Other