BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 9395109 · Received December 2, 2019

    Report

    Report Number
    3004753838-2019-097313
    Event Type
    Injury
    Date Received
    December 2, 2019
    Date of Event
    November 17, 2019
    Report Date
    December 2, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS.

    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. ON (B)(6) 2019 HE GOT UP AT 6:00 AM, GOT DRESSED, AND WENT TO THE KITCHEN WHERE HE COLLAPSED ON THE FLOOR (HE HAD NOT EATEN). THE CGM READING WAS 71 MG/DL AND IT HAD NOT ALARMED FOR A LOW VALUE (LOW THRESHOLD NOT PROVIDED). NO BG VALUE WAS TAKEN BUT HIS MOTHER REPORTED THAT IT WAS LOWER THAN HIS CGM AND HE WAS HYPOGLYCEMIC. IT TOOK HIM ABOUT 10 MINUTES TO WAKE UP AND THEN HE DID NOT FEEL NORMAL, SO HIS MOTHER CALLED 911 AND HE WAS TAKEN TO THE EMERGENCY ROOM. HE HAD UNSPECIFIED TESTS DONE AND WAS GIVEN SALINE VIA INTRAVENOUS (IV) THERAPY, EITHER MOTRIN OR EXTRA STRENGTH TYLENOL FOR A HEADACHE, AND JELL-O. HE ALSO BRUISED HIS SHOULDER AND BIT HIS TONGUE WHEN HE COLLAPSED. AT THE TIME OF CONTACT, HE WAS STILL VERY SORE FROM THE EVENT. WHEN COMPARISON VALUES WERE TAKEN LATER ON THE DAY OF THE EVENT, THE CGM READING WAS 229 MG/DL AND THE BG WAS 158 MG/DL. THEY CALIBRATED THE CGM AND THE NEXT DAY, (B)(6) 2019, THE VALUES WERE DISCREPANT IN THE OPPOSITE DIRECTION, WITH A CGM READING OF 113 MG/DL AND A BG OF 240 MG/DL. DATA WAS EVALUATED AND THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THERE WERE NO REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. THE DATA INVESTIGATION CONFIRMED A DIFFERENCE IN VALUES THAT FALLS WITHIN THE B ZONE OF THE PARKES ERROR GRID. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1190603 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9500-45 5262518 00386270000255

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Other