BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 22312068 · Received June 23, 2025

    Report

    Report Number
    3004753838-2025-160920
    Event Type
    Injury
    Date Received
    June 23, 2025
    Date of Event
    April 23, 2025
    Report Date
    June 23, 2025
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270004109
    PMA / PMN Number
    K213919
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA. 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 AN ADVERSE EVENT OCCURRED. ACCORDING TO THE PATIENT¿S CARETAKER, ON APPROXIMATELY (B)(6) 2025, THE CAREGIVER HAD TO BRING THE PATIENT TO THE HOSPITAL. THE PATIENT AND CARETAKER VISITED THE DOCTOR. THE PATIENT WAS SITTING IN THE CAR AND WAITING FOR THE CARETAKER TO RETURN FROM THE DOCTOR'S OFFICE. WHEN THE CARETAKER REACHED THE CAR, THE PATIENT WAS NOT FEELING WELL SO SHE DROVE HIM TO THE HOSPITAL TO HAVE HIM CHECKED. INITIALLY, THE HOSPITAL THOUGHT THAT HE MIGHT BE EXPERIENCING A BRAIN BLEED BUT IT TURNED OUT THAT HE WAS HYPOGLYCEMIC. THE CARETAKER CANNOT REMEMBER MUCH INFORMATION AS THE INCIDENT HAPPENED A MONTH AND A HALF AGO. THE PATIENT WAS DISCHARGED THAT SAME DAY. DEXCOM ATTEMPTED TO FOLLOW UP WITH THE PATIENT MULTIPLE TIMES TO OBTAIN FURTHER DETAILS AND CLARIFICATION REGARDING THE INCIDENT, BUT THEY WERE UNABLE TO MAKE CONTACT. THERE WAS NO DOCUMENTATION OF FURTHER MEDICAL EVALUATION OR INTERVENTION. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1671209 DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. NI NI 00386270004109

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Other