BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 16549587 · Received March 15, 2023

    Report

    Report Number
    3004753838-2023-057136
    Event Type
    Malfunction
    Date Received
    March 15, 2023
    Date of Event
    February 20, 2023
    Report Date
    March 15, 2023
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270001047
    PMA / PMN Number
    DEN170088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED SENSOR CRITICAL ALERT OCCURRED. THE SENSOR WAS ALLEGEDLY INSERTED INTO THE ABDOMEN ON (B)(6) 2023. DATA WAS EVALUATED AND THE ALLEGATION WAS CONFIRMED AS A EARLY SENSOR EXPIRATION WAS CONFIRMED. THE PROBABLE CAUSE WAS DETERMINE TO BE POTENTIAL PATIENT MISUSE WHICH LED TO AN EARLY SENSOR EXPIRATION. THE REPORTED EVENT OF AN UNSPECIFIED SENSOR CRITICAL ALERT IS REPORTABLE BASED ON THE FINDING OF AN EARLY SENSOR EXPIRATION. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835367 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9445-24 7314917 00386270001047

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female