BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 18869056 · Received March 8, 2024

    Report

    Report Number
    3004753838-2024-057262
    Event Type
    Injury
    Date Received
    March 8, 2024
    Date of Event
    December 23, 2023
    Report Date
    March 8, 2024
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    DEN170088
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 ABDOMEN. THE PATIENT HAD INACCURATE CGM VALUES IN (B)(6) 2023 AFTER THE SENSOR WAS INSERTED IN THE ABDOMEN. ON (B)(6) 2023, THE PATIENT EXPERIENCED FATIGUE, DIZZINESS, AND PASSED OUT. AT THE ONSET OF SYMPTOMS, THE DEXCOM ALERTED THE PATIENT TO HER HYPOGLYCEMIA; HOWEVER, SHE BELIEVED IT MAY HAVE BEEN HIGHLY INACCURATE READING. OF NOTE, THE PATIENT DEVICE MIGHT HAVE SHOWN 60 MG/DL; HOWEVER, SHE BELIEVED SHE COULD HAVE BEEN AT 20 MG/DL, BUT NO BG WAS CHECKED DURING THE EPISODE. THE PATIENT SELF-TREATED WITH CARBOHYDRATES AND WAS PROVIDED CARBOHYDRATES BY THE SPOUSE AND RECOVERED AFTER TREATMENT. AT THE TIME OF THE REPORT ON 2/9/2024, 48 DAYS AFTER THE EPISODE, THE PATIENT WAS COHERENT. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THERE WERE NO 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
    1060689 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Other