BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 22731737 · Received August 6, 2025

    Report

    Report Number
    3004753838-2025-213078
    Event Type
    Malfunction
    Date Received
    August 6, 2025
    Date of Event
    July 13, 2025
    Report Date
    December 22, 2025
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270002525
    PMA / PMN Number
    K213919
    Removal / Correction Number
    Z-1944-2025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). MDR REGULATORY AWARENESS DATE - CORRECTION. H2: CORRECTION/ADDITIONAL INFORMATION. H7: TYPE OF REMEDIAL ACTION - ADDITIONAL. H9: SECTION 21 USC 360 REPORT NO ¿ ADDITIONAL. 3004753838-2025-213078 WAS REPORTED IN ERROR. PLEASE DISREGARD INITIAL REPORTING OF THE MDR REGULATORY AWARENESS DATE, AS THIS INFORMATION SHOULD HAVE BEEN 7/13/2025.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ALERT/NOTIFICATION SETTINGS ISSUE OCCURRED. PRODUCT HAS BEEN RECEIVED BUT IS PENDING EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Description of Event or Problem · 0

    PRODUCT WAS PROVIDED FOR INVESTIGATION. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. RECEIVER CHARGE AND BOOT TESTS WERE PERFORMED AND PASSED. FUNCTIONAL TESTS WERE PERFORMED AND PASSED ALL RELEVANT TESTING. AN ALARM/ALERT MANUAL TEST WAS PERFORMED AND PASSED. AN INTERNAL VISUAL INSPECTION WAS PERFORMED AND FAILED DUE TO MOISTURE DAMAGE. PICTURES WERE TAKEN. THE SPEAKER AND VIBRATOR RESISTANCES WERE MEASURED AND PASSED. PERFORMANCE DATA WAS REVIEWED. AN ALERT/ NOTIFICATION SETTINGS ISSUE WAS NOT FOUND WITHIN THE INVESTIGATION WINDOW. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE INITIAL MDR, A CORRECTION AND ADDITIONAL INFORMATION IS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1288681 DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. P16494904 00386270002525

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female