BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 8826238 · Received July 25, 2019

    Report

    Report Number
    3004753838-2019-055868
    Event Type
    Injury
    Date Received
    July 25, 2019
    Date of Event
    July 3, 2019
    Report Date
    July 25, 2019
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270000255
    PMA / PMN Number
    DEN170088
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF DIABETIC KETOACIDOSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INACCURACIES BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND BLOOD GLUCOSE (BG) METER. THE SENSOR WAS INSERTED INTO THE ABDOMEN ON (B)(6) 2019. THE PATIENT'S FATHER STATED ON (B)(6) 2019, THE PATIENT¿S CGM VALUES WERE BETWEEN 120-220 MG/DL WHICH IS NORMAL FOR HIM. HOWEVER, THE PATIENT STARTED VOMITING IN THE MORNING AND CONTINUED UNTIL EARLY AFTERNOON EVEN AFTER TAKING ANTI-NAUSEA MEDICATION. HE WAS TAKEN TO THE EMERGENCY DEPARTMENT (ED), HIS BG WAS TESTED AND WAS OVER 960 MG/DL. THE PATIENT WAS ADMITTED TO THE ED FOR DIABETIC KETOACIDOSIS (DKA), TRANSFERRED TO CHILDREN¿S HOSPITAL WHERE HE WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU) UNTIL THE EVENING OF (B)(6) 2019. MEDICAL TREATMENT INCLUDED INTRAVENOUS (IV) FLUIDS, INSULIN, DEXTROSE, POTASSIUM, AND TELEMETRY. AT THE TIME OF CONTACT, THE PATIENT WAS DISCHARGED HOME AND IS DOING BETTER BUT IS NOT BACK TO BASELINE. DATA WAS EVALUATED AND THE ALLEGATION WAS NOT CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. THERE WERE NO REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620498 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9500-45 5253833 00386270000255

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Hospitalization| O