BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 6560486 · Received May 11, 2017

    Report

    Report Number
    3004753838-2017-41761
    Event Type
    Malfunction
    Date Received
    May 11, 2017
    Date of Event
    April 19, 2017
    Report Date
    April 19, 2017
    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). SENSORS MAY FRACTURE ON RARE OCCASIONS. IF A SENSOR BREAKS AND NO PORTION OF IT IS VISIBLE ABOVE THE SKIN, DO NOT ATTEMPT TO REMOVE IT. SEEK PROFESSIONAL MEDICAL HELP IF YOU HAVE SYMPTOMS OF INFECTION OR INFLAMMATION- REDNESS, SWELLING OR PAIN- AT THE INSERTION SITE.

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON (B)(6) 2017 THAT ON (B)(6) 2017, UPON REMOVAL OF THE SENSOR POD FROM THE PATIENT BODY, THE SENSOR WIRE BROKE. THE SENSOR INSERTION WAS AT THE ABDOMEN ON (B)(6) 2017. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. THE SENSOR (SERIAL NUMBER (B)(4), LOT NUMBER 5220439) WAS RETURNED FOR EVALUATION ON 05/10/2017. A VISUAL INSPECTION WAS PERFORMED AND THE SENSOR WIRE WAS DETACHED FROM THE HOUSING PUCK AND THE CANNULA WAS DETACHED FROM THE APPLICATOR HOUSING. THE COMPLAINT OF A BROKEN SENSOR WIRE WAS NOT CONFIRMED AS A BROKEN SENSOR WIRE WAS NOT OBSERVED. THE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, IT IS UNKNOWN IF THE RETURNED PRODUCT IS THE COMPLAINT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343510 DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR MDS DEXCOM, INC. 9500-27 NI 00386270000019

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR