BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 20996545 · Received December 21, 2024

    Report

    Report Number
    3004753838-2024-336237
    Event Type
    Injury
    Date Received
    December 21, 2024
    Date of Event
    November 24, 2024
    Report Date
    December 21, 2024
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    K213919
    Adverse Event
    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 HYPERGLYCEMIA. 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 ARM ON (B)(6) 2024. ON (B)(6) 2024, THE PATIENT STATED HIS CGM WAS READING 50 MG/DL. NO BG METER READING WAS TAKEN AT THIS TIME. THE PATIENT WAS FEELING SHAKY, SWEATY, AND WAS ¿SEMI-CONSCIOUS.¿ THE PATIENT¿S FRIEND CALLED EMERGENCY MEDICAL SERVICES (EMS). EMS ARRIVED AND TRANSPORTED THE PATIENT TO THE EMERGENCY ROOM. AT THE ER, THE PATIENT¿S BG METER READING WAS 386 MG/DL. NO CGM COMPARISON WAS REPORTED AT THIS TIME. THE PATIENT WAS TREATED WITH AN UNSPECIFIED IV. HE WAS DISCHARGED AFTER APPROXIMATELY THREE HOURS ONCE HIS BG LEVEL WAS STABLE. THE PATIENT WAS IN GOOD CONDITION AT THE TIME OF REPORT. DATA WAS EVALUATED AND THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. THE DATA INVESTIGATION FOUND A DIFFERENCE IN VALUES THAT FALLS 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
    2375607 DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9500-160 1824058005

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Other