BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 22031342 · Received May 15, 2025

    Report

    Report Number
    3004753838-2025-119310
    Event Type
    Injury
    Date Received
    May 15, 2025
    Date of Event
    May 2, 2025
    Report Date
    June 3, 2025
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270004109
    PMA / PMN Number
    K213919
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    SUBSEQUENT TO THE INITIAL MDR, ADDITIONAL INFORMATION BECAME AVAILABLE.

    Description of Event or Problem · 0

    THE COMPLAINT STATES THAT "CGM ACCURACY" WAS REPORTED. THE SENSOR WAS INSERTED INTO THE SKIN. ON 05/02/2025, IT WAS REPORTED BY THE PATIENT ON SPRINKLR THAT HE EXPERIENCED INACCURATE CGM VALUES. PER DOCUMENTATION, THE SENSORS ARE WAY OFF. THE PATIENT REPORTED "A LOT BRIEF ERRORS" (SEE 250514-008830). THE PATIENT ALSO HAD A SEIZURE FROM HYPOGLYCEMIA BG 39 MG/DL WHILE THE PHONE APP SHOWED CGM 113 MG/DL. THE PATIENT WOKE UP IN A HOSPITAL. NO OTHER DETAILS WERE DOCUMENTED. NO CONTACT INFORMATION WAS AVAILABLE FOR THE PATIENT, THEREFORE FOLLOW UP WAS NOT AVAILABLE. NO PRODUCT OR DATA WAS PROVIDED FOR INVESTIGATION. PROBLEM COULD NOT BE CONFIRMED AND PROBABLE CAUSE CANNOT BE DETERMINED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1897062 DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. NI 00386270004109

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other