BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 24040518 · Received January 12, 2026

    Report

    Report Number
    3004753838-2026-031376
    Event Type
    Injury
    Date Received
    January 12, 2026
    Date of Event
    November 1, 2025
    Report Date
    January 12, 2026
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    K213919
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPERGLYCEMIA.

    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 THE SAME DAY, IT WAS REPORTED THAT THE PATIENT GOT LOW EGV (UNSPECIFIED EGV) ALERTS FROM HER DEXCOM APP. WITHOUT A BG TEST, SHE DRANK SOME ORANGE JUICE. SHORTLY AFTER, SHE FELT WEAK, LETHARGIC AND EXPERIENCED SHAKINESS, AND HER DEXCOM APP WAS STILL SHOWING LOW READINGS (UNSPECIFIED EGV) SO SHE DECIDED TO DRIVE AND GO TO THE EMERGENCY ROOM (ER) FOR ASSESSMENT. AT THE ER, HER BG WAS MEASURED 569 MG/DL WHILE HER DEXCOM APP EGV WAS 70 MG/DL. SHE WAS GIVEN 12 UNITS OF INSULIN VIA INJECTION AND STAYED IN THE ER TO REST. WHEN SHE FELT FINE, SHE WAS DISCHARGED AND WENT HOME WITH A BG READINGS OF 100-125 MG/DL, BUT SHE TOOK OFF THE SENSOR AS IT WAS CONSISTENTLY INACCURATE. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THE REPORTED GLUCOSE VALUES FALL WITHIN THE D ZONE OF THE PARKES ERROR GRID. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97281 DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Other