BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 20860522 · Received December 6, 2024

    Report

    Report Number
    3004753838-2024-319649
    Event Type
    Injury
    Date Received
    December 6, 2024
    Date of Event
    November 8, 2024
    Report Date
    December 5, 2024
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    DEN170088
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

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

    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 ABDOMEN ON (B)(6) 2024. THE PATIENT EXPERIENCED A CGM ACCURACY ISSUE WHICH OCCURRED 3 DAYS AFTER SENSOR INSERTION INTO THE ABDOMEN. ON (B)(6) 2024, AROUND 8AM, THE PATIENT¿S CGM WAS READING BETWEEN 132-142 MG/DL AND THE PATIENT LOST CONSCIOUSNESS. NO BG METER COMPARISON VALUE WAS REPORTED. THE PATIENT WAS WEARING AN OMNIPOD INSULIN PUMP. AT SOME POINT AFTER THE PATIENT PASSED OUT, THE CGM PROVIDED AN ¿URGENT LOW¿ ALERT. THE PATIENT WAS BROUGHT TO THE EMERGENCY ROOM (IT WAS NOT SPECIFIED BY WHO). THE REPORTER THEN REFUSED TO PROVIDE DEXCOM WITH ANY FURTHER EVENT INFORMATION, AS SHE DID NOT WANT TO DISCLOSE ANY OF HER SON¿S MEDICAL INFORMATION. THE PATIENT WAS CURRENTLY IN THE HOSPITAL AT THE TIME OF THE REPORT. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. 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
    2290883 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Male Other OMNIPOD.