BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 21506532 · Received March 3, 2025

    Report

    Report Number
    3004753838-2025-050197
    Event Type
    Malfunction
    Date Received
    March 3, 2025
    Date of Event
    February 9, 2025
    Report Date
    May 6, 2026
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    K213919
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). B5: DESCRIBE EVENT OR PROBLEM - ADDITIONAL D9: DEVICE AVAILABILITY - ADDITIONAL H2: ADDITIONAL INFORMATION/DEVICE EVALUATION H3: DEVICE EVALUATED BY MANUFACTURER - ADDITIONAL H6: ADVERSE EVENT PROBLEM - ADDITIONAL.

    Additional Manufacturer Narrative · 0

    (B)(4). 3004753838-2025-050197 WAS REPORTED IN ERROR. PLEASE DISREGARD INITIAL REPORTING OF THIS EVENT AS THIS EVENT HAS NOW BEEN DEEMED NOT REPORTABLE.

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    THE PRODUCT WAS EVALUATED. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. RECEIVER CHARGE AND BOOT TESTS WERE PERFORMED AND PASSED. FUNCTIONAL TESTS WERE PERFORMED AND PASSED ALL RELEVANT TESTING. AN INTERNAL VISUAL INSPECTION WAS PERFORMED AND FAILED DUE TO MOISTURE DAMAGE. PICTURES WERE TAKEN. THE RECEIVER LOG WAS DOWNLOADED AND REVIEWED FINDING ERROR RELATED TO THE COMPLAINT. THE ALLEGATION WAS CONFIRMED. THE 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 RETURNED ON 5/21/2025 AND IT WAS DETERMINED THIS COMPLAINT IS NOT REPORTABLE PER CORPFT-140202

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNEXPECTED RECEIVER SHUTDOWN 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469059 DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. P15973467

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Female ROCHE ACCUCHECK INSIGHT PUMP.