BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 8146770 · Received December 10, 2018

    Report

    Report Number
    3004753838-2018-154137
    Event Type
    Malfunction
    Date Received
    December 10, 2018
    Date of Event
    November 13, 2018
    Report Date
    November 13, 2018
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270000385
    PMA / PMN Number
    DEN170088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PT'S MOM REPORTED SENSOR LOSS (B)(4) (B)(6) 2018 CLARIFICATION: ISSUE WAS SIGNAL LOSS: VERIFIED SIGNAL LOSS WAS PRESENT IN SHARE TOOL. UPDATED DISCUSSION/RESOLUTION TO INCLUDE OTHER REPLACEMENT AND RGA SENT OUT, AND UPDATED RGA TO CORRECT RGA NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    988733 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9445-02 5237088 00386270000385

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR