BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 16000905 · Received December 16, 2022

    Report

    Report Number
    3004753838-2022-235949
    Event Type
    Injury
    Date Received
    December 16, 2022
    Date of Event
    November 17, 2022
    Report Date
    December 16, 2022
    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
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

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

    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. AFTER DINNER ON (B)(6) 2022, THE PATIENT¿S TANDEM DISPLAYED 95 MG/DL AND HIS SPOUSE ADVISED HIM TO INGEST SOME FOOD BEFORE GOING TO BED. TEN MINUTES LATER, SHE CHECKED THE PATIENT AND HE WAS DAZED, CONFUSED AND NOT RESPONDING. SHE PERFORMED A BG WHICH WAS 23 MG/DL, GAVE THE PATIENT SOME ORANGE JUICE WHICH HE COULD NOT INGEST AS HE WAS ¿BARELY CONSCIOUS¿. SHE ADMINISTERED NASAL GLUCAGON (BAQSIMI); THIRTY MINUTES LATER, A REPEAT BG WAS PERFORMED WHICH WAS 65 MG/DL. THE PATIENT RECOVERED BUT REMAINED DROWSY AND TIRED FROM THE EVENT. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THERE WERE NO 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
    2747724 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9445-24 7313011 00386270000255

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Other TANDEM INSULIN PUMP