BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 23952174 · Received January 2, 2026

    Report

    Report Number
    3004753838-2026-001970
    Event Type
    Malfunction
    Date Received
    January 2, 2026
    Date of Event
    April 27, 2025
    Report Date
    January 7, 2026
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270001863
    PMA / PMN Number
    K213919
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). 3004753838-2026-001970 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

    DEXCOM BECAME AWARE THAT THE USER EXPERIENCED A FAILURE BUT DID NOT RECEIVE THE EXPECTED SENSOR FAILURE ALERT ON THEIR G7 CGM APPLICATION. PRODUCT WAS PROVIDED AND AN INVESTIGATION WAS PERFORMED. THE ROOT CAUSE WAS DETERMINED TO BE A CODING ISSUE. THE G7 CGM APPLICATION ONLY DETECTS THAT THE SESSION HAS ENDED, THUS, IT DOES NOT ALERT THE USER THAT THE SENSOR HAS FAILED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE INITIAL MDR, IT WAS DETERMINED THAT A REPORT WAS SUBMITTED IN ERROR. UPON FURTHER REVIEW, IT WAS DETERMINED THAT THE PATIENT ALLEGATION DOES NOT MEET THE CRITERIA OF A REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12297 DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9500-161 1824118001 00386270001863

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Male