BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 7909824 · Received September 26, 2018

    Report

    Report Number
    3004753838-2018-109621
    Event Type
    Injury
    Date Received
    September 26, 2018
    Date of Event
    August 30, 2018
    Report Date
    August 31, 2018
    Manufacturer
    DEXCOM, INC.
    Product Code
    PQF
    PMA / PMN Number
    P120005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON (B)(4) 2018 THAT ON (B)(6) 2018, THERE WAS AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER. THE SENSOR WAS INSERTED INTO THE ABDOMEN ON (B)(6) 2018. THE PATIENT'S MOTHER REPORTED THAT ON (B)(6) 2018 THE PATIENT HAD A SPASM AND CONVULSION WITH A FINGERSTICK VALUE OF 2.5 MMOL/L SO SHE CALLED EMERGENCY SERVICES. ACCORDING TO THE REPORTER, AT THE TIME OF THE CONVULSION THE DEXCOM CGM DISPLAYED 22.0 MMOL/L WHILE THE FINGERSTICK VALUE WAS 2.5 MMOL/L. WHEN EMERGENCY SERVICES ARRIVED, THEY ADMINISTERED GLUCOSE GEL AND THE PATIENT¿S FINGERSTICK VALUE WAS THEN REPORTED AS 5.0 MMOL/L AFTER GLUCOSE GEL. EMERGENCY SERVICES THEN LEFT AS THE PATIENT WAS IN GOOD CONDITION. THE REPORTER ALSO INDICATED AN EEG WAS RECOMMENDED BY A MEDICAL PROFESSIONAL. DATA WAS RECEIVED FOR EVALUATION, DATA REVIEW CONFIRMED THE REPORTED EVENT OF INACCURATE CGM VALUES. A PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752574 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR PQF DEXCOM, INC. 9500-44 5239882

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Other