BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 21930894 · Received April 29, 2025

    Report

    Report Number
    3004753838-2025-101819
    Event Type
    Injury
    Date Received
    April 29, 2025
    Date of Event
    April 17, 2025
    Report Date
    April 29, 2025
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    DEN170088
    Adverse Event
    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. H6 HEALTH EFFECT - CLINICAL CODE - E014302 DECREASED LEVEL 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) 2025. ON (B)(6) 2025, WHILE AT CHURCH, THE PATIENT FELT UNSTEADY, CLAMMY, AND WAS SWEATING. HE THEN PROGRESSED TO GETTING LETHARGIC AND WAS ¿STARTING NOT TO RESPOND¿. THE PATIENT¿S CGM WAS READING 350 MG/DL. NO BG METER READING WAS TAKEN FOR COMPARISON. THE PATIENT WAS WEARING AN OMNIPOD INSULIN PUMP. AFTER THE CHURCH SERVICE, A NURSE AT THE CHURCH GAVE THE PATIENT A SUGAR PACKET AND CALLED EMERGENCY MEDICAL SERVICES. EMS ARRIVED AND WAS TRANSPORTED TO THE EMERGENCY ROOM. AT THE ER, THE PATIENT¿S BG METER READING WAS 64 MG/DL AND THE CGM WAS READING 334 MG/DL. THE PATIENT WAS TREATED WITH AN UNSPECIFIED IV AND GIVEN A TURKEY SANDWICH AND CRACKERS WITH PEANUT BUTTER. AFTER TREATMENT, THE PATIENT¿S BG METER READING WAS 186 MG/DL AND THE CGM WAS READING 300 MG/DL. THE PATIENT WAS DISCHARGED HOME AFTER APPROXIMATELY 5 HOURS. THE PATIENT WAS ¿FEELING BETTER¿ AT THE TIME OF REPORT. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND THE 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
    1756306 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Male Other INSULET OMNIPOD5