BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 19047802 · Received April 4, 2024

    Report

    Report Number
    3004753838-2024-079635
    Event Type
    Injury
    Date Received
    April 4, 2024
    Date of Event
    February 29, 2024
    Report Date
    April 4, 2024
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    K213919
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    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 UNEXPECTED CGM APP SHUT-OFF OCCURRED. THE PATIENT RECEIVED AN ERROR MESSAGE ON THE DISPLAY DEVICE SCREEN OF "APP NOT WORKING." THE PATIENT RECEIVED THE ERROR MESSAGE PRIOR TO SYMPTOMS OF DIZZINESS. WHILE TRYING TO SOLVE THE ISSUE ON HIS OWN, HE WENT INTO A DIABETIC COMA AROUND 9:00-9:30AM. AFTER 45 MINUTES OF UNCONSCIOUSNESS, HIS GIRLFRIEND CAME HOME AND SAW HIM LYING ON THE FLOOR. HIS GIRLFRIEND THEN CALLED THE PARAMEDICS. WHEN THE PARAMEDICS CAME, THEY TOOK A FINGERSTICK AND THE VALUE WAS BELOW 29 MG/DL. THEY INJECTED SUGAR WATER INTO HIM AND AFTER A WHILE, HE WOKE UP. PARAMEDICS MONITORED HIS BG READINGS UNTIL IT WAS AROUND 200-212 MG/DL. THERE WAS NO INFORMATION OF TREATMENT FOR REBOUND HYPERGLYCEMIA. THE PATIENT FELT BETTER AFTER TREATMENT AND HE DID NOT GO TO THE HOSPITAL. PARAMEDICS LEFT THE HOUSE AROUND 12:30-1:00PM. AT THE TIME OF THE REPORT, THE PATIENT WAS IN STABLE CONDITION. DATA WAS EVALUATED AND THE ALLEGATION WAS CONFIRMED. THE 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
    76167 DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Other