BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 18566962 · Received January 23, 2024

    Report

    Report Number
    3004753838-2024-020212
    Event Type
    Injury
    Date Received
    January 23, 2024
    Date of Event
    December 25, 2023
    Report Date
    February 28, 2024
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    DEN170088
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF DIABETIC KETOACIDOSIS. H6 MEDICAL DEVICE PROBLEM CODE - 3191 - PATIENT WAS UNABLE TO IDENTIFY DEVICE ISSUE THEREFORE A MORE SPECIFIC CODE COULD NOT BE SELECTED.

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WERE NO CGM READINGS ON THE G6 MOBILE APP. ON (B)(6) 2023, THE PATIENT ATTEMPTED TO CHANGE HER TRANSMITTER, BUT SHE WAS UNABLE TO BECAUSE HER G6 APP STATED THAT THE ¿CRITICAL ALERTS ARE OFF¿. THE PATIENT REPORTED THAT SHE WAS UNABLE TO TURN ON THE CRITICAL ALERTS IN HER IOS SETTINGS. THEREFORE, THE PATIENT WAS NOT RECEIVING ANY CGM READINGS. DURING THE TIME THE PATIENT WAS WITHOUT CGM READINGS, THE PATIENT BECAME ¿VERY ILL¿ (NO PHYSICAL SYMPTOMS REPORTED). AT SOME POINT, THE PATIENT DID TEST HER BG VIA FINGERSTICK WHICH WAS 360 MG/DL. THE PATIENT¿S SON CALLED AN AMBULANCE. ONCE EMS ARRIVED, THE PATIENT WAS TRANSPORTED TO THE HOSPITAL. AT THE HOSPITAL, THE PATIENT¿S BG METER READING WAS 550 MG/DL, AND SHE WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS (DKA). THE PATIENT WAS TREATED WITH THE FOLLOWING MEDICATIONS WHILE HOSPITALIZED: LISPRO INSULIN, LISINOPRIL, TOPIRAMATE, LEVOXYL, REGLAN, WELLBUTRIN, ABILIFY, LYRICA, FAMOTIDINE, ROPINIROLE, SIMVASTATIN. THE PATIENT WAS DISCHARGED HOME 2 DAYS LATER. THE PATIENT WAS IN STABLE CONDITION AT THE TIME OF REPORT. DATA WAS RECEIVED BUT IS PENDING EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    DATA WAS PROVIDED FOR EVALUATION. EVALUATION OF THE DATA PERFORMANCE LOGS INDICATE THAT THE SENSOR SESSION WAS STARTED ON (B)(6) 2023 AT 12:15 AM. ON (B)(6) 2023 AT 6:10 PM THE USER RECEIVED THE FIRST OF MANY CRITICAL ALERTS PERMISSION REVOKED ALERTS. THIS ALERT TYPICALLY OCCURS WHEN THE USER SELECTS TO NOT TO ALLOW CRITICAL ALERTS TO USE THE APP DURING SET UP OF THE APP HOWEVER THIS PROBABLE CAUSE COULD NOT BE CONFIRMED IN THE DATA AND THE EXACT CAUSE OF THE ALERT WAS NOT FOUND. DATA LEADING UP TO THE REPORTED SERIOUS ADVERSE EVENT (SAE) INDICATES THAT THE USER WAS RECEIVING ONLY THE CRITICAL ALERT PERMISSION REVOKED AND THE END OF TX LIFE ALERTS DURING WHICH TIME HER SENSOR BEGAN EXPERIENCING TEMPORARY SENSOR FAILURE AND EVENTUALLY LEADING TO SENSOR FAILURE DUE TO PROGRESSIVE SENSOR DECLINE ON (B)(6) 2023. THIS CONDITION WAS PRESENT DURING THE SAE AND WAS NOT RESOLVED UNTIL THE PATIENT RE-INSTALLED THE APP AND SELECTED TO ALLOW CRITICAL ALERTS ON (B)(6) 2023. THE USER WORE THE SENSOR FOR 8 DAYS AND THE SENSOR SESSION ENDED ON (B)(6) 2023 AT 5:00 AM. THE REPORTED ALLEGATION WAS CONFIRMED VIA DATA. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849284 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Hospitalization| O