BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 24072616 · Received January 14, 2026

    Report

    Report Number
    3004753838-2026-041322
    Event Type
    Malfunction
    Date Received
    January 14, 2026
    Date of Event
    January 3, 2026
    Report Date
    April 12, 2026
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270004109
    PMA / PMN Number
    K213919
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). 3004753838-2026-041322 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 WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2026. DATA WAS RECEIVED BUT NOT INVESTIGATED AS DATA WILL NOT CONFIRM THE ISSUE. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO SERIOUS OR PROLONGED PATIENT HARM OR MEDICAL INTERVENTION WAS REPORTED.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE INITIAL MDR SUBMISSION, THE G7 WEARABLE WAS RECEIVED FOR EVALUATION ON (B)(6) 2026, AND THE APPLICATOR WAS RECEIVED ON (B)(6) 2026. THE INVESTIGATION WAS COMPLETED ON (B)(6) 2026. UPON FURTHER REVIEW, THE COMPLAINT WAS DETERMINED TO BE NOT REPORTABLE PER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133116 DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9500-161 1725285003 00386270004109

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male