BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 21690771 · Received March 25, 2025

    Report

    Report Number
    3004753838-2025-070084
    Event Type
    Malfunction
    Date Received
    March 25, 2025
    Date of Event
    February 27, 2025
    Report Date
    August 8, 2025
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    K213919
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). MFR # 3004753838-2025-070084 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 NEEDLE OR CANNULA OCCURRED. THE SENSOR WAS INSERTED INTO THE ABDOMEN, WHICH IS OFF LABEL USAGE OF THE DEVICE, ON 02-27-2025. 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 4/1/2025 AND IT WAS DETERMINED THIS COMPLAINT IS NOT REPORTABLE PER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1121374 DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9500-161 1724357002

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female INSULET OMNIPOD5