BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 8704500 · Received June 17, 2019

    Report

    Report Number
    3004753838-2019-48744
    Event Type
    Malfunction
    Date Received
    June 17, 2019
    Date of Event
    May 20, 2019
    Report Date
    June 17, 2019
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    DEN170088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PREMATURE SENSOR EXPIRATION OCCURRED. THE SENSOR WAS INSERTED INTO THE ARM ON (B)(6) 2019. DATA WAS PROVIDED FOR EVALUATION AND THE ALLEGATION WAS NOT CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497644 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9445-02 5250834

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR