BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 22857536 · Received August 21, 2025

    Report

    Report Number
    3004753838-2025-231270
    Event Type
    Malfunction
    Date Received
    August 21, 2025
    Date of Event
    July 13, 2025
    Report Date
    August 20, 2025
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270004093
    PMA / PMN Number
    K213919
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 250811-016817 125: MW5172761. 250811-012432 012: MW5172762. 250811-017612 125: MW5172763. 250811-017853 012: MW5172761.

    Description of Event or Problem · 0

    A VOLUNTARY MEDWATCH REPORT WAS RECEIVED ON 07/30/2025. IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. IT HAS BEEN REPORTED THAT THERE WAS A DIFFERENCE IN READINGS OF 150 POINTS. NO DATA WAS PROVIDED FOR EVALUATION. THE COMPLAINT CONFIRMATION AND PROBABLE CAUSE COULD NOT BE DETERMINED. THERE WERE NO REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2053509 DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. NI 00386270004093

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male