BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 24333473 · Received February 13, 2026

    Report

    Report Number
    3004753838-2026-091346
    Event Type
    Malfunction
    Date Received
    February 13, 2026
    Date of Event
    February 1, 2026
    Report Date
    March 17, 2026
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270004116
    PMA / PMN Number
    K213919
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A DEVICE ABNORMALITY; UNKNOWN MESSAGE. IT REPORTEDLY OCCURRED RARELY BETWEEN 2026-01-31 AND 2026-02-01. DATA WAS PROVIDED FOR INVESTIGATION. CONFIRMATION OF THE COMPLAINT COULD NOT BE DETERMINED BETWEEN 2026-01-31 AND 2026-02-01. THE PROBABLE CAUSE COULD NOT BE DETERMINED.. PRODUCT WAS ALSO PROVIDED FOR INVESTIGATION. CONFIRMATION OF THE ALLEGATION WAS NOT DETERMINED VIA PRODUCT AND DATA. A PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A DEVICE ABNORMALITY, UNKNOWN MESSAGE. IT REPORTEDLY OCCURRED RARELY BETWEEN (B)(6) 2026. DATA WAS PROVIDED FOR INVESTIGATION. CONFIRMATION OF THE COMPLAINT WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398301 DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9500-161 1825243011 00386270004116

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male TANDEM T:SLIM X2