BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 24251965 · Received February 3, 2026

    Report

    Report Number
    3004753838-2026-083165
    Event Type
    Malfunction
    Date Received
    February 3, 2026
    Date of Event
    January 29, 2026
    Report Date
    April 16, 2026
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270004116
    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). 3004753838-2026-083165 WAS REPORTED IN ERROR, PLEASE DISREGARD THE 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).

    Additional Manufacturer Narrative · 0

    (B)(4). 3004753838-2026-083165 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

    AFTER SUBMISSION OF THE INITIAL MDR PRODUCT WAS RECEIVED ON 3/4/2026. IT WAS DETERMINED THIS COMPLAINT IS NOT REPORTABLE PER CORPFT-140202

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A DETACHED OR MISSING SENSOR WIRE OCCURRED. THE SENSOR WAS INSERTED INTO THE ARM ON (B)(6) 2026. PRODUCT HAS BEEN RECEIVED BUT IS PENDING EVALUATION. A FOLLOW-UP WILL BE SUBMITTED UPON COMPLETION. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A DETACHED OR MISSING SENSOR WIRE OCCURRED. THE SENSOR WAS INSERTED INTO THE ARM ON (B)(6) 2026. DATA WAS RECEIVED BUT NOT INVESTIGATED AS DATA WILL NOT CONFIRM THE ISSUE. 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 3/4/2026. IT WAS DETERMINED THIS COMPLAINT IS NOT REPORTABLE PER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311072 DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9500-161 1825137007 00386270004116

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female TANDEM T:SLIM X2 INSULIN PUMP