BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 9662374 · Received February 3, 2020

    Report

    Report Number
    3013756811-2020-12636
    Event Type
    Malfunction
    Date Received
    February 3, 2020
    Date of Event
    January 11, 2020
    Report Date
    February 3, 2020
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE TANDEM USER GUIDE, ¿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 WAS AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) READING AND THE BLOOD GLUCOSE (BG) METER READING. REPORTEDLY, THE CGM BG READING WAS 66-70 MG/DL, AND THE METER BG READING WAS 202-255 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 REPLACEMENT SENSOR WAS SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123614 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9445-02 5263587

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR