BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 16882737 · Received May 5, 2023

    Report

    Report Number
    3004753838-2023-092271
    Event Type
    Malfunction
    Date Received
    May 5, 2023
    Date of Event
    April 5, 2023
    Report Date
    October 11, 2023
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    K213919
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ALERT SETTINGS ALTERED THEMSELVES. IT WAS INDICATED THAT THE PATIENT WAS USING AN UNSUPPORTED OPERATING SYSTEM, WHICH IS MISUSE OF THE DEVICE. DATA HAS BEEN RECEIVED BUT IS PENDING EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Description of Event or Problem · 0

    DATA WAS EVALUATED AND THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSE WAS DETERMINED TO BE THE SDK ALERT STATE MACHINE WAS RETURNING AN INVALID TRIGGER TIME THAT ENABLES AND DISABLES THE PROFILES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2195457 DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male