BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 16787162 · Received April 21, 2023

    Report

    Report Number
    3004753838-2023-081956
    Event Type
    Malfunction
    Date Received
    April 21, 2023
    Date of Event
    February 15, 2023
    Report Date
    April 21, 2023
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270001627
    PMA / PMN Number
    DEN170088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)94). 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED. 4316 - THE CONCLUDED CAUSE IS NOT ADEQUATELY DESCRIBED BY ANY OTHER TERM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CONNECTION ISSUES OCCURRED. DATA WAS EVALUATED AND THE ALLEGATION WAS CONFIRMED AS SIGNAL LOSS GREATER THAN AN HOUR WAS CONFIRMED. THE PROBABLE CAUSE WAS DETERMINED TO BE SIGNAL LOSS. THE PROBABLE CAUSE OF THE SIGNAL LOSS COULD NOT BE DETERMINED. THE REPORTED EVENT OF A CONNECTION ISSUES IS REPORTABLE BASED ON THE FINDING OF SIGNAL LOSS GREATER THAN AN HOUR. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865132 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9445-24 P14850462 00386270001627

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male