BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 22412692 · Received July 7, 2025

    Report

    Report Number
    3004753838-2025-173184
    Event Type
    Malfunction
    Date Received
    July 7, 2025
    Date of Event
    June 6, 2025
    Report Date
    August 8, 2025
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270002518
    PMA / PMN Number
    K213919
    Removal / Correction Number
    Z-1944-2025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 3004753838-2025-173184-01 WAS REPORTED IN ERROR. IN THE H7 SECTION, THE SUPPS TYPE OF REMEDIAL ACTION SHOULD HAVE BEEN CORRECTLY SELECTED AS "NOTIFICATION".

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    THE PRODUCT WAS EVALUATED. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. RECEIVER CHARGE AND BOOT TESTS WERE PERFORMED AND PASSED. FUNCTIONAL TESTS WERE PERFORMED AND THE AUDIO TEST FAILED. AN ALARM/ALERT MANUAL TEST WAS PERFORMED AND FAILED. AN INTERNAL VISUAL INSPECTION WAS PERFORMED AND FAILED DUE TO AN ASSEMBLY ERROR; IT WAS NOTED THE SPEAKER INSTALLED TILTED. PICTURES WERE TAKEN. THE SPEAKER AND VIBRATOR RESISTANCES WERE MEASURED AND PASSED. THE PERFORMANCE DATA WAS REVIEWED FINDING NO ERROR RELATED TO THE COMPLAINT. THE ALLEGATION WAS CONFIRMED AS NO AUDIO OUTPUT. THE PROBABLE CAUSE WAS DETERMINED TO BE ASSEMBLY ERROR VIA PRODUCT. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1153641 DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 18038141 00386270002518

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male TRESIBA INSULIN PEN