BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G6 SENSORS

    MDR report key: 14696149 · Received June 14, 2022

    Report

    Report Number
    MW5110333
    Event Type
    Injury
    Date Received
    June 14, 2022
    Date of Event
    June 11, 2022
    Report Date
    June 13, 2022
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270001047
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I USE THE DEXCOM G6 CONTINUOUS GLUCOSE METER FOR DIABETES AND A HISTORY OF SUDDEN, RAPID ONSET HYPOGLYCEMIA. IN MARCH I DROPPED FROM THE 140'S TO 43 IN ABOUT 2 MINUTES. THE LAST FOUR SENSORS I HAVE PLACED HAVE HAD CATASTROPHIC FAILURES. THE LAST 3 WERE ALL FROM THE SAME BOX. THE ONE BEFORE WAS A DIFFERENT BOX AND I MAY NOT HAVE SEALED THE ADHESIVE 100%. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1846211 DEXCOM G6 SENSORS SENSOR, GLUCOSE, INVASIVE MDS DEXCOM, INC. G6 5302299 00386270001047
    1846212 DEXCOM G6 SENSORS SENSOR, GLUCOSE, INVASIVE MDS DEXCOM, INC.
    1846213 DEXCOM G6 SENSORS SENSOR, GLUCOSE, INVASIVE MDS DEXCOM, INC.
    1846214 DEXCOM G6 SENSORS SENSOR, GLUCOSE, INVASIVE MDS DEXCOM, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Male Required Intervention| O AIMOVIG| ALBUTEROL | CALCIUM| CLONAZEPAM | DAILY MULTI-VITAMIN| FENTANYL | FLORINEF| HUMIRA| HYDROCORTISONE| METHYLPHENIDATE| SINGULAIR | TRELEGY | TRIAZOLAM| VITAMIN D