BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 15610105 · Received October 14, 2022

    Report

    Report Number
    3004753838-2022-192932
    Event Type
    Injury
    Date Received
    October 14, 2022
    Report Date
    October 14, 2022
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270000866
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). VOLUNTARY MEDWATCH REPORT NUMBER MW5111821. DIABETES MELLITUS IS A KNOWN CAUSE OF HYPERGLYCEMIA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE SENSOR WAS INSERTED INTO THE ARM, WHICH IS OFF LABEL USAGE OF THE DEVICE ON (B)(6) 2022. THE PATIENT STATED THEY USE THE DEXCOM G6 AND THE TANDEM INSULIN PUMP TO MANAGE THEIR DIABETES. FOR SEVERAL MONTHS LEADING UP TO THIS REPORT OF AN EMERGENCY ROOM VISIT IN JUNE 2021, THEY HAVE HAD ISSUES WITH PREVIOUS SENSORS THAT PROVIDED INACCURATE INACCURATE RESULTS (SOMETIMES THE CGN WOULD BE OVER 100 MG/DL OFF FROM THEIR BG TESTER) ¿PUTTING ME DANGEROUS SITUATIONS WITH MY CONTROL IQ SYSTEM ON THE X:2 INSULIN PUMP SINCE IT DELIVERS LESS INSULIN FOR LOW BLOOD SUGAR LEVELS AND INCREASES INSULIN DELIVERY FOR HIGH BLOOD SUGAR LEVELS.¿ ON (B)(6) 2022, THE PATIENT UNPLUGGED THEIR PUMP WHEN THEY WERE LOW TO AVOID ANY INSULIN DELIVERY SINCE THE PUMP WOULD OFTEN SAY SHE WAS 180MG/DL OR HIGHER AND WOULD CONTINUE TO DELIVER ELEVATED INSULIN LEVELS WHEN SHE DID NOT NEED IT. PRIOR TO UNPLUGGING THE INSULIN PUMP, THE PATIENT CALIBRATED THE CGM SEVERAL TIMES AND THE DEXCOM WAS NOT ABLE TO ¿SELF-CORRECT AND RE-CALIBRATE¿. THE PATIENT FORGOT TO PLUG THE INSULIN PUMP BACK IN WHEN THEY HAD DINNER. THIS LED TO ELEVATED BLOOD SUGAR LEVELS OF OVER 300 BY THE TIME THE PATIENT REALIZED THAT THEY NEEDED TO PLUG THE INSULIN PUMP BACK IN. THE PATIENT¿S HUSBAND DROVE THE PATIENT TO THE EMERGENCY ROOM (ER) WHERE THEIR BG LEVELS CONTINUED TO INCREASE UNTIL IT WAS WELL OVER 450 MG/DL. THE PATIENT WAS SEVERELY DEHYDRATED AND REQUIRED AN INSULIN DRIP TO BRING THEIR NUMBERS BELOW 250 MG/DL. THE PATIENT WAS RELEASED FROM THE ER AFTER 6HRS (B)(6)2022. NO DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2666339 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. NI 7282154 00386270000866

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female Other TANDEM INSULIN PUMP