BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 22921843 · Received August 29, 2025

    Report

    Report Number
    3004753838-2025-240809
    Event Type
    Malfunction
    Date Received
    August 29, 2025
    Date of Event
    August 5, 2025
    Report Date
    September 15, 2025
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270000590
    PMA / PMN Number
    DEN170088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 3004753838-2025-240809 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

    AFTER SUBMISSION OF THE INITIAL MDR, PRODUCT WAS RECEIVED ON 8/19/2025. IT WAS DETERMINED THIS COMPLAINT IS NOT REPORTABLE PER (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND THE PROBABLE CAUSE COULD NOT BE DETERMINED. IT HAS BEEN REPORTED THAT SOMETIMES THERE WAS A DIFFERENCE IN READINGS OF 20 POINTS. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2222511 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. MT24078 5246660 00386270000590

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female