BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 6477379 · Received April 10, 2017

    Report

    Report Number
    3004753838-2017-29724
    Event Type
    Malfunction
    Date Received
    April 10, 2017
    Date of Event
    March 8, 2017
    Report Date
    March 17, 2017
    Manufacturer
    DEXCOM, INC.
    Product Code
    PQF
    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). THE G5 SYSTEM IS ASSOCIATED WITH PRODUCT CODE PQF.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON 03/17/2017 THAT ON (B)(6) 2017 THE SENSOR WIRE WAS MISSING. THE ATTEMPTED SENSOR INSERTION WAS AT THE ABDOMEN. 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 5220425) WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED AND THE SENSOR WIRE WAS MISSING FROM THE SENSOR; HOWEVER, THE NEEDLE IS SAFELY RETRACTED INSICE THE APPLICATOR BODY. THE CUSTOMER COMPLAINT WAS CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED. THE RETURNED SENSOR WAS NOT THE COMPLAINT SENSOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257917 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR PQF DEXCOM, INC. 9500-27 5220197 00386270000019

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR