BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 16400834 · Received February 17, 2023

    Report

    Report Number
    3004753838-2023-039447
    Event Type
    Injury
    Date Received
    February 17, 2023
    Date of Event
    January 21, 2023
    Report Date
    February 17, 2023
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    40386270000253
    PMA / PMN Number
    DEN170088
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

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

    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) 2023. ON (B)(6) 2023, THE PATIENT FELT ILL AND EXPERIENCED NAUSEA AND DIZZINESS. THE CGM WAS READING 400 MG/DL AND THE BLOOD GLUCOSE READING WAS 600 MG/DL. HE ATTEMPTED TO TREAT HIMSELF WITH UNSPECIFIED TYPE AND DOSE OF INSULIN, BUT WHEN HIS SYMPTOMS AND HYPERGLYCEMIA DID NOT IMPROVE SO HE WENT TO THE EMERGENCY DEPARTMENT (ED). HE WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS (DKA) AND TREATED WITH IV INSULIN DRIP. HE WAS DISCHARGED AFTER 5 HOURS AND DID NOT REQUIRE HOSPITALIZATION. DATA WAS EVALUATED AND THE ALLEGATION WAS CONFIRMED. THE REPORTED GLUCOSE VALUES FALL WITHIN THE B ZONE OF THE PARKES ERROR GRID. THE DATA INVESTIGATION FOUND A DIFFERENCE IN VALUES THAT FALL WITHIN THE B ZONE OF THE PARKES ERROR GRID. THE PRODUCT WAS NOT EVALUATED BECAUSE SENSOR HAS BEEN COMPROMISED AND THE ENVIRONMENT IN WHICH THE SYSTEM FAILED CANNOT BE REPLICATED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA OR PRODUCT INVESTIGATION. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557190 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9445-24 NI 40386270000253

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Other