BEUDAMED
    FDA Adverse Event Death Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 8582725 · Received May 6, 2019

    Report

    Report Number
    3004753838-2019-039551
    Event Type
    Death
    Date Received
    May 6, 2019
    Date of Event
    November 28, 2018
    Report Date
    January 7, 2020
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    P120005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MDR, ADDITIONAL INFORMATION WAS PROVIDED BY TANDEM ON 12/09/2019. IT WAS REPORTED THE PATIENT DIED OF A HYPOGLYCEMIC EVENT. THE PATIENTS WIFE REPORTED TO THE TANDEM SALES REPRESENTATIVE THAT THE CGM WAS NOT ALERTING THE PATIENT WHEN HIS BLOOD GLUCOSE (BG)WENT LOW. THE PATIENTS WIFE ALLEGED THE CONTINUOUS GLUCOSE MONITOR (CGM) DID NOT NOTIFY THE PATIENTS BG WAS LOW AND THE TANDEM PUMP CONTINUED TO DELIVER INSULIN. THE PATIENT DID NOT HAVE CGM-TANDEM PUMP INTEGRATION AND MANUAL DOSING OF INSULIN WITH THE PUMP WAS REQUIRED. THE CGM DEVICE GENERATION WAS NOT PROVIDED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PASSED AWAY ON (B)(6) 2018 DUE TO A HYPOGLYCEMIC EVENT. THE PATIENT WAS WEARING THE DEXCOM G5 SYSTEM AT THE TIME OF EVENT; HOWEVER, DEXCOM IS NOT AWARE OF ANY ALLEGATIONS AGAINST THE PRODUCT. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377396 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Death| O TANDEM PUMP