BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 12480330 · Received September 16, 2021

    Report

    Report Number
    3013756811-2021-99128
    Event Type
    Injury
    Date Received
    September 16, 2021
    Date of Event
    August 14, 2021
    Report Date
    September 16, 2021
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    P120005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    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 CUSTOMER WAS HOSPITALIZED DUE TO LOW BLOOD GLUCOSE (BG). REPORTEDLY, CUSTOMER RECEIVED AN ALERT OF LOW BG VALUE AND THE PUMP DELIVERED A CORRECTION BOLUS OF 1.5 UNITS. CUSTOMER THEN DELIVERED ANOTHER CORRECTION BOLUS OF 3.5 UNITS. TWO HOURS LATER, CUSTOMER WAS UNRESPONSIVE, EXPERIENCING CRAMPS AND COLD SWEATS, AND WAS ADMITTED TO THE HOSPITAL. AT THE HOSPITAL, IT WAS FOUND THAT THERE WAS AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) READING AND THE BLOOD GLUCOSE (BG) METER READING. THE CGM BG READING WAS 162-163 MG/DL, 108-109 MG/DL, 342-343 MG/DL, AND THE METER BG READING WAS 41 MG/DL, 63 MG/DL, 324-325 MG/DL. REPORTEDLY, CUSTOMER WAS TREATED INTRAVENOUSLY WITH GLUCOSE, AND WAS RELEASED FROM THE HOSPITAL WITH NO PERMANENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1381549 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9445-02

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R