BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 6546208 · Received May 4, 2017

    Report

    Report Number
    3004753838-2017-38418
    Event Type
    Malfunction
    Date Received
    May 4, 2017
    Date of Event
    April 14, 2017
    Report Date
    April 14, 2017
    Manufacturer
    DEXCOM, INC.
    Product Code
    PQF
    UDI-DI
    00386270000019
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 (B)(6) 2017 THAT ON (B)(6) 2017, UPON REMOVAL OF THE SENSOR POD FROM THE PATIENT BODY, THE SENSOR WIRE WAS MISSING. THE SENSOR WAS INSERTED AT THE UPPER BUTTOCKS ON (B)(6) 2017. 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 ((B)(4)/LOT NUMBER 5223480) WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED AND THE SENSOR WIRE WAS MISSING FROM THE SENSOR POD AND SEAL CARRIER. THE CUSTOMER COMPLAINT WAS CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, THE SENSOR THAT WAS RETURNED WAS NOT THE PRODUCT AT FAULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327069 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR PQF DEXCOM, INC. 9500-27 5223415 00386270000019

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR