BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 5846499 · Received August 4, 2016

    Report

    Report Number
    3004753838-2016-61494
    Event Type
    Malfunction
    Date Received
    August 4, 2016
    Date of Event
    July 8, 2016
    Report Date
    July 8, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000224
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PATIENT'S MOTHER CONTACTED DEXCOM ON (B)(6) 2016 TO REPORT A LOSS OF CONNECTION BETWEEN THE TRANSMITTER AND SMART DEVICE THAT OCCURRED ON (B)(6) 2016. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED. PRODUCT DATA WAS RETURNED FOR EVALUATION. DATA WAS REVIEWED ON 07/22/2016. THE REPORTED EVENT OF LOSS OF CONNECTION WAS CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    A TRANSMITTER (SERIAL NUMBER (B)(4)/LOT NUMBER 5211691) WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED AND NO DEFECTS WERE FOUND. FUNCTIONAL TESTING AND A PAIRING TEST WAS PERFORMED AND THE TESTS PASSED. THE REPORTED EVENT OF A LOSS OF CONNECTION WAS NOT CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED. PLEASE NOTE THAT THE PRODUCT THAT WAS RETURNED IS NOT THE COMPLAINT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499433 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9438-06 5211691 00386270000224

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR