BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 25060915 · Received May 1, 2026

    Report

    Report Number
    3004753838-2026-143754
    Event Type
    Malfunction
    Date Received
    May 1, 2026
    Date of Event
    April 8, 2026
    Report Date
    May 11, 2026
    Product Code
    QBJ
    UDI-DI
    00386270002518
    PMA / PMN Number
    K213919
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). 3004753838-2026-143754 WAS REPORTED IN ERROR, PLEASE DISREGARD THE INITIAL REPORTING OF THIS EVENT AS THIS EVENT HAS NOW BEEN DEEMED NOT REPORTABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ERROR ICON DISPLAY OCCURRED. 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

    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 CRITERIA OF A REPORTABLE EVENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165691 DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ 17856623 00386270002518

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male