BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 19635589 · Received June 28, 2024

    Report

    Report Number
    3004753838-2024-154169
    Event Type
    Injury
    Date Received
    June 28, 2024
    Date of Event
    May 31, 2024
    Report Date
    June 28, 2024
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    K213919
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ALERT/NOTIFICATION OCCURRED. IT WAS INDICATED THAT THE PATIENT WAS USING AN UNSUPPORTED OPERATING SYSTEM, WHICH IS MISUSE OF THE DEVICE. ON (B)(6) 2024, IT WAS REPORTED THAT THE PATIENT WAS DRIVING WHEN HIS EYES BEGAN TO FEEL HEAVY AND HE PASSED OUT AT THE WHEEL, WHICH RESULTED IN A CAR ACCIDENT (HITTING A TELEPHONE POLE). THE PATIENT REGAINED CONSCIOUSNESS ON HIS OWN AFTER A FEW SECONDS. THE PATIENT REPORTED HE DID NOT RECEIVE ANY LOW ALERTS OR NOTIFICATIONS FROM EITHER HIS APPLE WATCH OR THE DEXCOM APP OR HIS IPHONE. THE PATIENT¿S APPLE WATCH AUTOMATICALLY CALLED 911 AROUND 2PM. ONCE EMS ARRIVED, THE PATIENT¿S BG METER WAS READING 39 MG/DL WHILE THE CGM WAS READING LOW MG/DL. EMS TREATED THE PATIENT WITH GLUCOSE GEL AND GLUCOSE TABLETS. THE PATIENT DECLINED BEING BROUGHT TO THE ER. EMS RELEASED THE PATIENT ONCE HIS BG METER READING WAS 98 MG/DL. AS A RESULT OF THE CAR ACCIDENT, THE PATIENT SUFFERED 2ND DEGREE BURNS, BLISTERING OF THE SKIN, AND BRUISING ON HIS LEFT ARM DUE TO HIS AIRBAG DEPLOYING. THE FOLLOWING DAY, ON (B)(6) 2024, THE PATIENT WENT TO THE ER TO HAVE HIS BURNS EVALUATED (CAPTURED IN 240612-017936). THE PATIENT WAS EXPERIENCING BODY ACHES AND STILL REVERING FROM THE 2ND DEGREE BURNS AT THE TIME OF REPORT. PERFORMANCE DATA WAS REVIEWED. THE ALLEGATION WAS UNDETERMINED VIA DATA. HOWEVER, IT WAS FOUND THAT AN APP CRASH OCCURRED WITHIN THE INVESTIGATION WINDOW. 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
    2185530 DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9500-161 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Male Other