BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 7861865 · Received September 10, 2018

    Report

    Report Number
    3004753838-2018-105596
    Event Type
    Injury
    Date Received
    September 10, 2018
    Date of Event
    August 15, 2018
    Report Date
    August 16, 2018
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270000255
    PMA / PMN Number
    P170031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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, THE PATIENT EXPERIENCED AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER AND AN ADVERSE EVENT. DATE OF ISSUE IS AN APPROXIMATION. THE SENSOR WAS INSERTED INTO THE ABDOMEN ON (B)(6) 2018. THE PATIENT¿S MOTHER STATED BEFORE GOING TO BED ON (B)(6) 2018, THEY CHECKED THEIR OMNIPOD AND STATED THE PATIENT¿S BG LEVEL WAS AT 288 MG/DL AND THEY DID NOT PROVIDE A CGM VALUE. BASED ON THE READING FROM THE BG METER, THE PATIENT¿S MOTHER GAVE THE PATIENT A CORRECTION INSULIN. ON THE MORNING OF (B)(6) 2018, AT 5:15AM, THE PATIENT¿S BG METER WAS CHECKED AGAIN; AND THE PATIENT WAS AT 321 MG/DL. THE PATIENT WAS TESTED FOR KETONES USING STRIPS AND IT WAS INDICATED THAT THE PATIENT TESTED POSITIVE. THE PATIENT¿S MOTHER CORRECTED THE PATIENT¿S BG LEVELS AGAIN AND AT 4:14PM, THE PATIENT STATED THEY WERE NOT FEELING WELL AND COULD NOT SEE. THE PATIENT¿S MOTHER TESTED THE PATIENT¿S BG AND THE PATIENT WAS AT 264 MG/DL AND CALLED FOR AN AMBULANCE. THE PATIENT WAS TRANSPORTED TO THE CHILDREN¿S HOSPITAL AT AROUND 4:40PM. THEY TESTED THE PATIENT¿S BG AND HE WAS AT 184 MG/DL AND HAD HIS VITALS CHECKED. NO FURTHER TREATMENT WAS MADE, AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ADDITIONALLY, THE PATIENT¿S MOTHER STATED THEY DID NOT CHECK THE CGM FOR COMPARISONS TO THE BG METER AND DESPITE THAT, THEY REPORTED THE VALUES WERE INACCURATE. AT THE TIME OF CONTACT, THE PATIENT WAS IN STABLE CONDITION. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE. NO PRODUCT OR DATA WAS PROVIDED FOR INVESTIGATION. CONFIRMATION OF THE COMPLAINT WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702975 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9500-45 NI 00386270000255

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Other OMNIPOD