BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 10731045 · Received October 23, 2020

    Report

    Report Number
    3004753838-2020-125067
    Event Type
    Malfunction
    Date Received
    October 23, 2020
    Date of Event
    September 22, 2020
    Report Date
    January 4, 2021
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270000385
    PMA / PMN Number
    DEN170088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). B5 DESCRIBE EVENT OR PROBLEM -ADDITIONAL INFORMATION. D9 DEVICE AVAILABILITY - ADDITIONAL INFORMATION. H2 ADDITIONAL INFORMATION/ DEVICE EVALUATION. H3 DEVICE EVALUATED BY MANUFACTURER - ADDITIONAL INFORMATION. H6. ADVERSE EVENT PROBLEM - ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    THE PRODUCT WAS EVALUATED. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. VOLTAGE TEST WAS PERFORMED AND FAILED DUE TO 0V.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNKNOWN ERROR "SESSION HAS ENDED I HAVE A NEW TRANSMITTER" OCCURRED. DATA WAS EVALUATED AND THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSE WAS DETERMINED TO BE A TRANSMITTER FAILED ERROR. THE REPORTED ALLEGATION OF AN UNKNOWN ERROR "SESSION HAS ENDED I HAVE A NEW TRANSMITTER" IS REPORTABLE BASED ON THE FINDING OF A TRANSMITTER FAILED ERROR. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1189388 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9445-02 7269712 00386270000385

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR