BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 10943327 · Received December 4, 2020

    Report

    Report Number
    3013756811-2020-133210
    Event Type
    Malfunction
    Date Received
    December 4, 2020
    Date of Event
    November 14, 2020
    Report Date
    December 3, 2020
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 80, 72, 61, LOW AND 63 MG/DL, AND THE METER BG READING WAS 133, 135, 145, 155 AND 215 MG/DL. 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
    1411942 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9445-02 5278426

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR