BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 16645834 · Received March 30, 2023

    Report

    Report Number
    3004753838-2023-068853
    Event Type
    Injury
    Date Received
    March 30, 2023
    Date of Event
    March 2, 2023
    Report Date
    March 30, 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
    FL, 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 ABDOMEN ON (B)(6) 2023. THE PATIENT WAS ASYMPTOMATIC AND GOING ABOUT HER NORMAL ROUTINE AND RECEIVING UNSPECIFIED HIGH VALUES ON THE CGM. THE PATIENT WAS ABOUT TO DOSE HER INSULIN BASED ON HIGH CGM VALUES BUT THE GRANDDAUGHTER ASSISTED THE PATIENT IN CHECKING THE BG PRIOR TO DOSING. THE BG VALUE WAS LOW AT 21 MG/DL. THE PATIENT THEN EXPERIENCED SPEECH DIFFICULTIES, INCOHERENCE, AND SEIZURE AND A FAMILY MEMBER CALLED 911. UPON ARRIVAL, EMERGENCY MEDICAL SERVICES (EMS) TREATED THE HYPOGLYCEMIA WITH AN UNSPECIFIED SUGAR IV AND THE PATIENT RECOVERED AFTER TREATMENT. SOME TIME AFTER TREATMENT, THE CGM REMAINED INACCURATE WITH EGV 230-257 MG/DL AND BG 145-149 MG/DL. AT THE TIME OF THE REPORT, THE PATIENT WAS FEELING FINE. NO DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. THE REPORTED GLUCOSE VALUES FALL WITHIN THE B ZONE OF THE PARKES ERROR GRID. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226596 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9445-24 NI 40386270000253

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Other