BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 22390119 · Received July 2, 2025

    Report

    Report Number
    3004753838-2025-171070
    Event Type
    Injury
    Date Received
    July 2, 2025
    Date of Event
    June 20, 2025
    Report Date
    July 2, 2025
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270003935
    PMA / PMN Number
    K213919
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON (B)(6) 2025 AT APPROXIMATELY 9:30 PM THE PATIENT CONTACTED 911 DUE TO CONCERNS ABOUT INCONSISTENT GLUCOSE READINGS. AT THE TIME, THE PATIENT HAD BEEN ASLEEP BUT AWOKE SHAKING AND SWEATING. UPON CHECKING HIS DEXCOM (CGM), THE READING SHOWED 98 MG/DL, WHILE HIS BLOOD GLUCOSE (BG) METER DISPLAYED ¿LOW¿ (BELOW 20 MG/DL). THE PATIENT REPORTED SELF-ADMINISTERING 300 MG OF GALDOPIN (DOXEPIN, A TRICYCLIC ANTIDEPRESSANT/SEDATIVE) WITHIN THE PAST 24 HOURS PRIOR TO THE ARRIVAL OF EMERGENCY MEDICAL SERVICES (EMS. NO OTHER MEDICATIONS WERE TAKEN. HE CONTINUED TO MONITOR HIS GLUCOSE LEVELS, WITH DEXCOM READINGS FLUCTUATING BETWEEN 40¿80 MG/DL (EXACT VALUES UNCERTAIN), WHILE THE BG METER CONTINUED TO SHOW ¿LOW.¿ EMERGENCY MEDICAL SERVICES (911) ARRIVED AND REMAINED AT THE PATIENT¿S RESIDENCE FOR APPROXIMATELY 30 MINUTES. DURING THEIR VISIT, THE PATIENT RECEIVED TWO GLUCOSE INJECTIONS (MEANT TO BE GLUCAGON). FOLLOWING TREATMENT, THE DEXCOM READINGS INCREASED TO APPROXIMATELY 100¿114 MG/DL (PATIENT UNSURE), AND THE BG METER SHOWED A READING OF 270 MG/DL. THE PATIENT WAS OKAY AT THE TIME OF THE REPORT. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND THE PROBABLE CAUSE COULD NOT BE DETERMINED. THE REPORTED GLUCOSE VALUES FALL WITHIN THE C ZONE OF THE PARKES ERROR GRID. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1794340 DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9500-161 1725057007 00386270003935

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male Other INSULIN PUMP.