BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 10675610 · Received October 13, 2020

    Report

    Report Number
    3013756811-2020-110027
    Event Type
    Malfunction
    Date Received
    October 13, 2020
    Date of Event
    September 24, 2020
    Report Date
    October 13, 2020
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TANDEM USER GUIDE STATES, ¿MAKE SURE A SENSOR GLUCOSE READING SHOWS IN THE UPPER RIGHT PORTION OF THE CGM HOME SCREEN BEFORE CALIBRATING.¿ NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE MULTIPLE INACCURACIES BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) READING AND THE BLOOD GLUCOSE (BG) METER READING. REPORTEDLY, THE CGM BG READINGS WERE 47 AND LOW MG/DL, AND THE METER BG READINGS WERE 250, 180, 347, AND 317 MG/DL. REPORTEDLY, THE CUSTOMER ENTERED CALIBRATION VALUES DURING PERIODS WHEN NO CGM VALUES WERE PRESENT. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE. A ROOT CAUSE COULD NOT BE DETERMINED. A REPLACEMENT SENSOR WAS SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1132981 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9445-02 5278754

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR