BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 22563750 · Received July 22, 2025

    Report

    Report Number
    3004753838-2025-191619
    Event Type
    Malfunction
    Date Received
    July 22, 2025
    Date of Event
    June 24, 2025
    Report Date
    September 16, 2025
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270003225
    PMA / PMN Number
    DEN170088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 3004753838-2025-191619 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).

    Additional Manufacturer Narrative · 0

    (B)(4). B5: DESCRIBE EVENT OR PROBLEM - ADDITIONAL INFORMATION. D9: DEVICE RETURNED TO MFR - ADDITIONAL INFORMATION. D9: DATE DEVICE RETURNED - ADDITIONAL INFORMATION. H2: TYPE OF FOLLOW UP - ADDITIONAL INFORMATION/ DEVICE EVALUATION. H3: DEVICE EVALUATED BY MFG - ADDITIONAL INFORMATION. H6: ADDITIONAL INFORMATION. H11: ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    AFTER SUBMISSION OF THE INITIAL MDR, PRODUCT WAS RECEIVED ON 7/28/2025 AND IT WAS DETERMINED THIS COMPLAINT IS NOT REPORTABLE PER (B)(4).

    Description of Event or Problem · 0

    THE COMPLAINT STATES THAT "RECEIVER REINITIALIZATION" WAS REPORTED. NO PRODUCT OR DATA WAS PROVIDED FOR INVESTIGATION. PROBLEM COULD NOT BE CONFIRMED AND PROBABLE CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A RECEIVER REINITIALIZATION OCCURRED. THE PRODUCT WAS EVALUATED. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. A RECEIVER CHARGE AND BOOT WAS PERFORMED AND FAILED DUE TO RECEIVER PERPETUALLY REBOOTING. PERFORMANCE DATA WAS NOT REVIEWED DUE TO RECEIVER PERPETUALLY REBOOTING. THE RECEIVER CASE WAS OPENED, AND AN INTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. CONFIRMATION OF THE ALLEGATION AND PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    944480 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 18498540 00386270003225

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female