BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 6077609 · Received November 3, 2016

    Report

    Report Number
    3004753838-2016-54006
    Event Type
    Malfunction
    Date Received
    November 3, 2016
    Date of Event
    October 12, 2016
    Report Date
    October 12, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000019
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

    A SENSOR (SERIAL NUMBER (B)(4)/LOT NUMBER 5211358) WAS RETURNED FOR EVALUATION A VISUAL INSPECTION WAS PERFORMED AND THE SENSOR WIRE WAS MISSING FROM THE SENSOR POD AND HOUSING PUCK. DUE TO THE MISSING SENSOR WIRE, THE SENSOR WIRE IS CONSIDERED DETACHED. THE REPORTED EVENT OF A MISSING SENSOR WIRE WAS CONFIRMED. A 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
    728366 DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR MDS DEXCOM, INC. 9500-27 5211399 00386270000019

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR