BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 21551861 · Received March 7, 2025

    Report

    Report Number
    3004753838-2025-055510
    Event Type
    Injury
    Date Received
    March 7, 2025
    Date of Event
    February 24, 2025
    Report Date
    March 7, 2025
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    DEN170088
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 SENSOR WAS INSERTED INTO THE ARM, WHICH IS OFF-LABEL USAGE OF THE DEVICE, ON (B)(6) 2025. ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT EXPERIENCED INACCURATE CGM VALUES. THE MOBILE DEVICE SHOWED SENSOR ERROR (SR 250227-002444) AND LOW CGM. THE PATIENT TOOK GLUCOSE TABLETS. SOMETIME LATER, THE PATIENT HAD ABDOMINAL PAIN, DIZZINESS, AND WAS NAUSEATED. THE BG WAS 500 MG/DL. THE PATIENT WAS ADVISED BY THE DOCTOR TO GO TO THE HOSPITAL. THERE, THE BG WAS 600 MG/DL. SHE WAS TREATED WITH INSULIN, IV FLUIDS AND PAIN MEDICATION. SHE WAS DISCHARGED AT 3AM WITH BG 300 MGDL. THERE WAS NO DOCUMENTATION OF FURTHER MEDICAL EVALUATION OR INTERVENTION FOR HYPERGLYCEMIA. THE PATIENT WAS DOING FINE DURING THE CALL. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. WHEN THE PATIENT HAS ABDOMINAL PAIN, THE REPORTED GLUCOSE VALUES FALL WITHIN THE D ZONE OF THE PARKES ERROR GRID. AT THE HOSPITAL, THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. 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
    1233150 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Other