BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 10946244 · Received December 4, 2020

    Report

    Report Number
    3004753838-2020-146379
    Event Type
    Malfunction
    Date Received
    December 4, 2020
    Date of Event
    November 7, 2020
    Report Date
    February 10, 2021
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270000385
    PMA / PMN Number
    DEN170088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). B5: DESCRIBE EVENT OR PROBLEM - ADDITIONAL . H2: ADDITIONAL INFORMATION/DEVICE EVALUATION . H3: DEVICE EVALUATED BY MANUFACTURER - ADDITIONAL . H6: ADVERSE EVENT PROBLEM - ADDITIONIAL - CORRECTION PLEASE OMIT H6 CODES FROM INITIAL SUBMISSION 11, 3233.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TRANSMITTER FAILED ERROR OCCURRED. THE PRODUCT WAS EVALUATED. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. VOLTAGE TEST WAS PERFORMED AND FAILED DUE TO 0 VDC. A REVIEW OF THE SHARE LOGS WAS PERFORMED AND TRANSMITTER FAILED ERROR WAS FOUND WITHIN THE INVESTIGATION WINDOW. THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSE WAS DETERMINED TO BE A LOW TRANSMITTER BATTERY. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TRANSMITTER FAILED ERROR OCCURRED. DATA WAS EVALUATED AND THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSE WAS DETERMINED TO BE A LOW TRANSMITTER BATTERY. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1412116 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9445-02 5275851 00386270000385

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR