BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEI

    MDR report key: 5243959 · Received November 23, 2015

    Report

    Report Number
    3004753838-2015-77486
    Event Type
    Malfunction
    Date Received
    November 23, 2015
    Date of Event
    October 30, 2015
    Report Date
    October 30, 2015
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000019
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM ON (B)(6) 2015 TO REPORT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITORING (CGM) SYSTEM AND THE BLOOD GLUCOSE (BG) METER ON (B)(6) 2015. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774595 NEI MDS MDS DEXCOM, INC. 9500-27 NI 00386270000019

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR