BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 20535835 · Received October 25, 2024

    Report

    Report Number
    3004753838-2024-278291
    Event Type
    Injury
    Date Received
    October 25, 2024
    Date of Event
    September 28, 2024
    Report Date
    October 25, 2024
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270001771
    PMA / PMN Number
    DEN170088
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA. H6: MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ADVERSE EVENT OCCURRED. THE SENSOR WAS INSERTED INTO THE SKIN. ON (B)(6) 2020, IT WAS REPORTED THAT THE PATIENT EXPERIENCED A HYPOGLYCEMIC EPISODE THE SATURDAY PRIOR TO THE CALL. SHE EXPERIENCED SYNCOPE AND REQUIRED HOSPITALIZATION. THE BEHAVIOR OF THE DISPLAY DEVICE WAS NOT SPECIFIED BY THE PATIENT NOR CLARIFIED BY TS. THE REVERSAL OF HYPOGLYCEMIA WAS NOT SPECIFIED BY THE PATIENT NOR CLARIFIED BY TS. THE LENGTH OF STAY IN THE HOSPITAL WAS NOT SPECIFIED BY THE PATIENT NOR CLARIFIED BY TS. THE PATIENT'S CONDITION AT THE TIME OF THE REPORT WAS NOT SPECIFIED BY THE PATIENT NOR CLARIFIED BY TS. ATTEMPTS TO CONTACT THE PATIENT FOR MORE DETAILS ABOUT THE EPISODE WERE UNSUCCESSFUL. AT THE TIME OF CONTACT, IT WAS INDICATED THAT THE PATIENT WAS STABLE. DATA WAS PROVIDED FOR INVESTIGATION. THE ALLEGATION WAS CONFIRMED VIA DATA AS A SIGNAL LOSS EQUAL TO OR UNDER ONE HOUR. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889976 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 18780442 00386270001771

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Female Hospitalization| O