BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 5873283 · Received August 12, 2016

    Report

    Report Number
    3004753838-2016-91816
    Event Type
    Malfunction
    Date Received
    August 12, 2016
    Date of Event
    July 21, 2016
    Report Date
    July 21, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000019
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    PATIENT'S MOTHER CONTACTED DEXCOM ON (B)(6) 2016 TO REPORT CONTINUOUS GLUCOSE MONITORING (CGM) INACCURACIES COMPARED TO BLOOD GLUCOSE (BG) METER THAT OCCURRED ON (B)(6) 2016. SENSOR WAS INSERTED ON (B)(6) 2016. AT THE TIME OF CONTACT, NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524679 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR MDS DEXCOM, INC. 9500-27 NI 00386270000019

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR