BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 6168230 · Received December 12, 2016

    Report

    Report Number
    3004753838-2016-71757
    Event Type
    Malfunction
    Date Received
    December 12, 2016
    Date of Event
    November 19, 2016
    Report Date
    November 20, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000019
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ON RARE OCCASIONS, THE SENSOR WIRE MAY BREAK OR DETACH FROM THE SENSOR POD. IF A SENSOR WIRE BREAKS UNDER THE SKIN WITH NO PORTION OF IT VISIBLE, DON'T REMOVE IT. CONTACT YOUR HEALTHCARE PROFESSIONAL IF YOU HAVE REDNESS, SWELLING, OR PAIN AT THE INSERTION SITE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON 11/20/2016 THAT ON (B)(6) 2016, UPON REMOVAL OF THE SENSOR POD FROM THE PATIENT BODY, THE SENSOR WIRE BROKE. THE SENSOR INSERTION WAS AT THE UPPER BUTTOCKS ON (B)(6) 2016. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WERE PROVIDED FOR EVALUATION. THE REPORTED BROKEN SENSOR WIRE COULD NOT BE CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    A SENSOR (PART NUMBER STS-GL-011/SERIAL NUMBER (B)(4)/LOT NUMBER 5211742) WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED AND THE SENSOR WIRE WAS ATTACHED TO THE SENSOR POD AND SEAL CARRIER. THE CUSTOMER COMPLAINT WAS NOT CONFIRMED BECAUSE THE SENSOR WIRE IS NOT BROKEN. A ROOT CAUSE COULD NOT BE DETERMINED; HOWEVER, IT IS UNKNOWN IF THER RETURNED SENSOR IS THE PRODUCT AT FAULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817721 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