BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 18820422 · Received March 1, 2024

    Report

    Report Number
    3004753838-2024-051727
    Event Type
    Malfunction
    Date Received
    March 1, 2024
    Date of Event
    February 29, 2024
    Report Date
    June 25, 2024
    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).

    Additional Manufacturer Narrative · 0

    (B)(4). PLEASE DISREGARD THE MDR REGULATORY AWARENESS DATE ON SUBMISSION (3004753838-2024-051727 ; CI1709323233871.23830881@FDSAHL86CEB41E_TE2) AS THIS WAS SELECTED IN ERROR. THE CORRECT MDR REGULATORY AWARENESS DATE SHOULD BE 03/01/2024.

    Additional Manufacturer Narrative · 0

    B5: DESCRIBE EVENT OR PROBLEM - CORRECTION. H2: IF FOLLOW-UP, WHAT TYPE - CORRECTION. H6: ADVERSE EVENT PROBLEM - CORRECTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NO ALERT/NOTIFICATION OCCURRED. PERFORMANCE DATA WAS REVIEWED. THE ALLEGATION WAS CONFIRMED DUE TO THE FINDING OF NO ALERT/NOTIFICATION. THE PROBABLE CAUSE WAS DETERMINED TO BE ASSEMBLY ERROR. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE INITIAL MDR, A CORRECTION IS REQUIRED.

    Description of Event or Problem · 0

    THE ALLEGATION WAS UNDETERMINED VIA DATA. HOWEVER, IT WAS FOUND THAT AN APP CRASH OCCURRED WITHIN THE INVESTIGATION WINDOW. THE PROBABLE CAUSE COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1919999 DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male