BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 18883222 · Received March 12, 2024

    Report

    Report Number
    3004753838-2024-059102
    Event Type
    Malfunction
    Date Received
    March 12, 2024
    Date of Event
    February 20, 2024
    Report Date
    March 29, 2024
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    K213919
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN APP CRASH ALERT OCCURRED. NO DATA OR PRODUCT WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Description of Event or Problem · 0

    HTTPS://DEXCOMCOMPLAINTS.LIGHTNING.FORCE.COM/LIGHTNING/R/COMPLAINT__C/A127V000008FNGNQAY/VIEW#:~:TEXT=IT%20WAS%20REPORTED%20THAT%20AN%20APP%20CRASH%20ALERT%20OCCURRED.%20DATA%20WAS%20EVALUATED%20AND%20THE%20ALLEGATION%20WAS%20UNDETERMINED.%20THE%20PROBABLE%20CAUSE%20COULD%20NOT%20BE%20DETERMINED.%20HOWEVER%2C%20POTENTIAL%20PATIENT%20MISUSE%20OCCURRED%20AS%20THE%20MOBILE%20DEVICE%20LOST%20POWER.%20NO%20INJURY%20OR%20MEDICAL%20INTERVENTION%20WAS%20REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1029150 DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male