BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 10833775 · Received November 12, 2020

    Report

    Report Number
    3004753838-2020-135975
    Event Type
    Malfunction
    Date Received
    November 12, 2020
    Date of Event
    September 15, 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
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT RETURNED FOR EVALUATION: EXTERIOR PHYSICAL VISUAL INSPECTION: PASSED. -EST TRANSMITTER VOLTAGE: FAIL (0V).

    Description of Event or Problem · 0

    PRODUCT WAS RETURNED FOR INVESTIGATION. AN EXTERIOR PHYSICAL VISUAL INSPECTION WAS PERFORMED AND PASSED. A TEST WAS RUN ON THE TRANSMITTER VOLTAGE AND FAILED AT 0V.

    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. THE PROBABLE CAUSE WAS DETERMINED TO BE SIGNAL LOSS. IN ADDITION, THE PROBABLE CAUSE OF THE SIGNAL LOSS COULD NOT BE DETERMINED. THE REPORTED EVENT OF A PAIRING FAILURE IS REPORTABLE BASED ON THE FINDING OF THE SIGNAL LOSS OVER AN HOUR. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1292404 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9445-02 7272947 00386270000385

    Patients

    Seq Age Sex Outcome Treatment
    1 118 YR