BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 7212485 · Received January 23, 2018

    Report

    Report Number
    3004753838-2018-008219
    Event Type
    Malfunction
    Date Received
    January 23, 2018
    Date of Event
    December 10, 2017
    Report Date
    December 24, 2017
    Manufacturer
    DEXCOM, INC.
    Product Code
    PQF
    UDI-DI
    00386270000002
    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). THE PATIENT EXPERIENCED A PRODUCT PROBLEM ON DIFFERENT DAYS WITH THE SAME DEVICE. THE FOLLOWING REPORTS ARE BEING SUBMITTED: 171224-000591,171224-000631,171224-000632,171224-000633,171224-000635,171224-000654,171224-000655,171224-000658,171224-000660,171224-000661,171224-000683,171224-000726,171224-000727,171224-000728,171224-000731,171224-000758,171224-000759,171224-000761,171224-000763,171224-000764,171224-000771,171224-000776,171224-000799,171224-000801,171224-000802,171224-000821,171224-000822,171224-000825,171224-000826,171224-000827.

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON (B)(4) 2017 THAT ON (B)(6) 2017 A LOSS OF CONNECTION BETWEEN THE TRANSMITTER AND SMART DEVICE OCCURRED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. DATA WAS RETURNED AND EVALUATED. THE REPORTED EVENT OF A LOSS OF CONNECTION WAS CONFIRMED VIA DATA. THE PROBABLE CAUSE COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55712 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR PQF DEXCOM, INC. N/A 00386270000002

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR