BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 10840392 · Received November 13, 2020

    Report

    Report Number
    3004753838-2020-136603
    Event Type
    Malfunction
    Date Received
    November 13, 2020
    Date of Event
    October 5, 2020
    Report Date
    December 18, 2020
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270000385
    PMA / PMN Number
    DEN170088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 INFORMATION. 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 PAIR NEW TRANSMITTER OCCURRED. DATA WAS EVALUATED AND THE ALLEGATION WAS CONFIRMED AS A TRANSMITTER FAIL ERROR. THE PROBABLE CAUSE WAS DETERMINED TO BE TRANSMITTER FAILED ERROR. THE REPORTED EVENT OF A PAIR 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
    1303955 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9445-02 5274305 00386270000385

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR