BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 19774193 · Received July 18, 2024

    Report

    Report Number
    3004753838-2024-172593
    Event Type
    Malfunction
    Date Received
    July 18, 2024
    Date of Event
    June 21, 2024
    Report Date
    August 10, 2024
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    DEN170088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). B5: DESCRIBE EVENT OR PROBLEM ¿ CORRECTION. G6:TYPE OF REPORT: FOLLOW UP. H2: ADDITIONAL INFORMATION - CORRECTION. H6: INVESTIGATION CONCLUSION ¿ ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    HTTPS://DEXCOMCOMPLAINTS.LIGHTNING.FORCE.COM/LIGHTNING/R/COMPLAINT__C/A12PH000008UUXRYAQ/VIEW#:~:TEXT=IT%20WAS%20REPORTED%20THAT%20A%20DEXCOM%20APP%20CRASH%20OCCURRED.%20NO%20DATA%20OR%20PRODUCT%20WAS%20PROVIDED%20FOR%20EVALUATION.%20THE%20ALLEGATION%20AND%20A%20PROBABLE%20CAUSE%20COULD%20NOT%20BE%20DETERMINED.%20NO%20INJURY%20OR%20MEDICAL%20INTERVENTION%20WAS%20REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A DEXCOM APP CRASH OCCURRED. DATA HAS BEEN RECEIVED BUT IS PENDING EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1551546 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Female