BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 11195635 · Received January 19, 2021

    Report

    Report Number
    3004753838-2021-12913
    Event Type
    Malfunction
    Date Received
    January 19, 2021
    Date of Event
    August 22, 2020
    Report Date
    January 20, 2021
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270000385
    PMA / PMN Number
    DEN170088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    B5 --DATE RECEIVED BY MANUFACTURER CORRECTED IN G3 TO 01/17/2021 AS THE WRONG YEAR WAS RECORDED. G3 DATE RECEIVED BY MANUFACTURER CORRECTED TO 01/17/2021.

    Description of Event or Problem · 0

    DATE RECEIVED BY MANUFACTURER CORRECTED IN G3 TO 01/17/2021 AS THE WRONG YEAR WAS RECORDED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PAIRING FAILURE OCCURRED. DATA WAS EVALUATED AND THE ALLEGATION WAS CONFIRMED. AN EXTERIOR PHYSICAL VISUAL INSPECTION WAS PERFORMED AND PASSED. A TRANSMITTER VOLTAGE TEST WAS PERFORMED AND FAILED. A REVIEW OF THE SHARE LOGS WAS PERFORMED AND A PAIRING FAILURE WAS NOT FOUND WITHIN THE INVESTIGATION WINDOW. THE ALLEGATION WAS NOT CONFIRMED. IN ADDITION, TRANSMITTER FAILED ERROR WAS FOUND IN CONNECTION TO THE REPORTED ALLEGATION. THE REPORTED EVENT OF A PAIRING FAILURE 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
    92305 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9445-02 7271269 00386270000385

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR