BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 18853187 · Received March 6, 2024

    Report

    Report Number
    3004753838-2024-055482
    Event Type
    Injury
    Date Received
    March 6, 2024
    Date of Event
    December 24, 2023
    Report Date
    March 18, 2024
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    DEN170088
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    (B)(4). "THE PATIENT STAYED AT THE HOSPITAL FOR 1 DAY AND WAS DISCHARGED THE NEXT DAY (B)(6) 2023."

    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. THE PATIENT EXPERIENCED INACCURATE CGM VALUES AFTER THE SENSOR WAS INSERTED IN THE ARM. ON (B)(6) 2023, THE PATIENT REPORTEDLY STARTED THROWING UP, SO SHE WAS RUSHED TO THE HOSPITAL BY HER FATHER WHERE SHE WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS. ALTHOUGH THE PATIENT ALLEGED SENSOR INACCURACY, THE BG AND CGM VALUES WERE NOT REMEMBERED. IT WAS NOT SPECIFIED NOR CLARIFIED WHETHER THE SENSOR HAD HIGH OR LOW INACCURACY. THE PATIENT WAS TREATED AND WAS PROVIDED MEDICATION BUT COULD NOT RECALL WHAT IT WAS. THE PATIENT STAYED AT THE HOSPITAL FOR 1 DAY AND WAS DISCHARGED THE NEXT DAY (B)(6) 2023. AT THE TIME OF THE REPORT ON 02/09/2024, 47 DAYS AFTER THE EPISODE, THE PATIENT WAS FEELING GOOD. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND THE PROBABLE CAUSE COULD NOT BE DETERMINED. THERE WERE NO REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    THE PATIENT STAYED AT THE HOSPITAL FOR 1 DAY AND WAS DISCHARGED THE NEXT DAY (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1534776 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Female Other| H