BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 5363696 · Received January 13, 2016

    Report

    Report Number
    3004753838-2016-00416
    Event Type
    Malfunction
    Date Received
    January 13, 2016
    Date of Event
    December 17, 2015
    Report Date
    December 17, 2015
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000019
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM ON (B)(6) 2015, TO REPORT A SENSOR WIRE THAT WENT MISSING AFTER IT DETACHED ON (B)(6) 2015. SENSOR WAS INSERTED AT THE ABDOMEN ON (B)(6) 2015. PATIENT REPORTED THAT THE TRANSMITTER WAS SNAPPED INTO THE SENSOR POD WHEN THE SENSOR WAS REMOVED. PATIENT WAS NOT ABLE TO LOCATE THE SENSOR WIRE AFTER IT DETACHED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    A SENSOR (SERIAL # (B)(4)/LOT #5203000) WAS RETURNED FOR EVALUATION; HOWEVER IT COULD NOT BE VERIFIED IF THIS IS THE COMPLAINT DEVICE. A VISUAL INSPECTION WAS PERFORMED AND FOUND THAT THE WIRE IS MISSING FROM THE SENSOR POD AND HOUSING PUCK. THE CUSTOMER'S COMPLAINT OF A MISSING/DETACHED SENSOR WIRE WAS CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23164 DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-27 NI 00386270000019

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR