BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 20352169 · Received October 2, 2024

    Report

    Report Number
    3004753838-2024-253975
    Event Type
    Malfunction
    Date Received
    October 2, 2024
    Date of Event
    September 8, 2024
    Report Date
    November 22, 2024
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    DEN170088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 3004753838-2024-253975 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

    SUBSEQUENT TO THE INITIAL MDR, IT WAS DETERMINED THAT A REPORT WAS SUBMITTED IN ERROR. UPON FURTHER REVIEW, IT WAS DETERMINED THAT THE PATIENT ALLEGATION DOES NOT MEET THE CRITERIA OF A REPORTABLE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SIGNAL LOSS OCCURRED. IT WAS DETERMINED THAT LOSS OF CONNECTION WAS RELATED TO THE MOBILE APPLICATION. PERFORMANCE DATA WAS REVIEWED. THE ALLEGATION WAS CONFIRMED DUE TO THE FINDING OF SIGNAL LOSS OVER AN HOUR WITHIN THE INVESTIGATION WINDOW. THE PROBABLE CAUSE WAS THE TRANSMITTER AND APP WERE UNABLE TO ESTABLISH A CONNECTION. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45639 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male