BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 7816626 · Received August 27, 2018

    Report

    Report Number
    3004753838-2018-097729
    Event Type
    Malfunction
    Date Received
    August 27, 2018
    Date of Event
    July 27, 2018
    Report Date
    July 27, 2018
    Manufacturer
    DEXCOM, INC.
    Product Code
    PQF
    UDI-DI
    00386270000002
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT EXPERIENCED ADVERSE EVENTS ON DIFFERENT DAYS WITH THE SAME DEVICE. THE FOLLOWING REPORTS ARE BEING SUBMITTED: 180727-001678

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON 07/27/2018, THAT ON (B)(6) 2018, A LOSS OF CONNECTION OCCURRED. IT WAS DETERMINED THAT LOSS OF CONNECTION WAS RELATED TO THE MOBILE APPLICATION. DATA WAS PROVIDED FOR EVALUATION. THE REPORTED ISSUE WAS CONFIRMED. THE PROBABLE CAUSE WAS DETERMINED TO BE NO COMMUNICATION GAP IN LOGS. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON (B)(4) 2018 THAT ON (B)(6) 2018 A LOSS OF CONNECTION HAD OCCURRED. NO PRODUCT WAS PROVIDED FOR EVALUATION HOWEVER DATA HAS BEEN RECEIVED FOR INVESTIGATION. A FOLLOW-UP WILL BE SUBMITTED UPON COMPLETION OF DATA INVESTIGATION. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. IT WAS DETERMINED THAT LOSS OF CONNECTION WAS RELATED TO THE MOBILE APPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660374 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR PQF DEXCOM, INC. N/A 00386270000002

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR