BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 7509590 · Received May 12, 2018

    Report

    Report Number
    3004753838-2018-050608
    Event Type
    Malfunction
    Date Received
    May 12, 2018
    Date of Event
    April 10, 2018
    Report Date
    April 13, 2018
    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 ADVERSE EVENTS ON DIFFERENT DAYS. THE FOLLOWING REPORTS ARE BEING SUBMITTED: 180413-001422; 180413-001458.

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON 4/13/2018, THAT ON (B)(6) 2018, A LOSS OF CONNECTION OCCURRED. A DATA INVESTIGATION WILL NOT BE PERFORMED AS SIGNAL LOSS UP TO ONE HOUR IS WITHIN SPECIFICATION. NO ADDITIONAL EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352090 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR PQF DEXCOM, INC. N/A 00386270000002

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR