BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 21599327 · Received March 13, 2025

    Report

    Report Number
    3004753838-2025-061006
    Event Type
    Malfunction
    Date Received
    March 13, 2025
    Date of Event
    February 18, 2025
    Report Date
    July 21, 2025
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    K213919
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). 3004753838-2025-061006 WAS REPORTED IN ERROR. PLEASE DISREGARD INITIAL REPORTING OF THIS EVENT AS THIS EVENT HAS NOW BEEN DEEMED NOT REPORTABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A DETACHED OR MISSING SENSOR WIRE OCCURRED. THE SENSOR WAS INSERTED INTO THE ABDOMEN, WHICH IS OFF LABEL USAGE OF THE DEVICE, ON (B)(6) 2025. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Description of Event or Problem · 0

    AFTER SUBMISSION OF THE INITIAL MDR PRODUCT WAS RECEIVED ON 3/20/2025 IT WAS DETERMINED THIS COMPLAINT IS NOT REPORTABLE PER CORPFT-140202.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823145 DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9500-161 1824337005

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male HUMALOG/LANTUS