BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 21576648 · Received March 11, 2025

    Report

    Report Number
    3004753838-2025-058218
    Event Type
    Injury
    Date Received
    March 11, 2025
    Date of Event
    March 1, 2025
    Report Date
    March 11, 2025
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    K213919
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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 INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE SENSOR WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON 03/01/2025, IT WAS REPORTED THAT THE PATIENT EXPERIENCED INACCURATE CGM VALUES. THE DAY OF THE EVENT THE PATIENT THE PATIENT´S BLOOD PRESSURE SUDDENLY DROPPED, THE PATIENT EXPERIENCED DIZZINESS, AND LOST CONSCIOUSNESS. WHEN THE PATIENT LOST CONSCIOUSNESS, THEY HURT THEIR HEAD AND SHOULDER. THE CGM READING WOULD HAVE BEEN READING IN A NORMAL RANGE, AND THE PATIENT STATED THEY SUSPECT THEY LOST CONSCIOUSNESS DUE TO A LOW BLOOD GLUCOSE LEVEL AT THAT TIME. AN AMBULANCE WAS CALLED AND WHEN A FINGERSTICK WAS TAKEN THE CGM WAS READING 130-131 MG/DL, AND THE BLOOD GLUCOSE READING WAS 68 MG/DL. THE PATIENT WAS UNKNOWN IF ANY MEDIATION WAS PROVIDED WHILE SHE WAS UNCONSCIOUS. AN ELECTROCARDIOGRAM WAS DONE BY THE PARAMEDICS, WHICH WAS NORMAL. WHEN THE BLOOD PRESSURE WAS TAKEN THIS WAS LOW. THE PATIENT STATED THEY BELIEVE THAT THEY LOST CONSCIOUSNESS DUE A COMBINATION OF LOW BLOOD PRESSURE AND LOW BLOOD SUGAR LEVELS. THE PATIENT WAS BROUGHT TO THE HOSPITAL. AT THE HOSPITAL A CT OF THE HEAD AND AN X-RAY OF THE CHEST AND SHOULDERS WERE MADE. NO INJURY WAS REPORTED, BUT THE PATIENT WAS GIVEN TRAMADOL AND HYDROCODONE FOR SUSTAINED PAIN IN THE SHOULDER AND NECK THAT SHE SUFFERED AFTER SHE PASSED OUT. THE PATIENT WAS ALSO GIVEN HER NORMAL NIGHTTIME MEDICATION. THE DAY OF THE REPORT, WHICH WAS THE SAME DAY AS THE DAY OF THE EVENT, THE PATIENT STATED THAT SHE WAS ADVISED TO STAY OVERNIGHT BUT STATED THAT SHE WAS ¿QUITE BETTER¿. THERE WAS NO DOCUMENTATION OF FURTHER MEDICAL EVALUATION OR INTERVENTION. AT THE TIME OF THE REPORT THE PATIENT WAS STABLE. DATA WAS EVALUATED AND THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THE REPORTED GLUCOSE VALUES FALL WITHIN THE C ZONE OF THE PARKES ERROR GRID. THE DATA INVESTIGATION FOUND A DIFFERENCE IN VALUES THAT FALLS 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
    1148799 DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9500-161 1824285007

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Other