BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G6

    MDR report key: 10494127 · Received September 3, 2020

    Report

    Report Number
    MW5096439
    Event Type
    Injury
    Date Received
    September 3, 2020
    Date of Event
    August 30, 2020
    Report Date
    September 2, 2020
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE PATIENT IS USING A DIY LOOP SYSTEM. HIS DEXCOM G6 READ REPEATEDLY IN THE RANGE OF 203 - 239 MG/DL AT A TIME WHEN HIS FINGERSTICK GLUCOSE WAS 36 MG/DL. THE SYSTEM CONTINUED TO GIVE HIM INSULIN BASED ON HIS DEXCOM READINGS AT A TIME WHEN HE WAS SERIOUSLY HYPOGLYCEMIC. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    956728 DEXCOM G6 INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED QBJ DEXCOM, INC. G6 5276282

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Life Threatening