BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 7904227 · Received September 24, 2018

    Report

    Report Number
    3004753838-2018-112266
    Event Type
    Malfunction
    Date Received
    September 24, 2018
    Date of Event
    August 27, 2018
    Report Date
    August 27, 2018
    Manufacturer
    DEXCOM, INC.
    Product Code
    PQF
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PLEASE DISREGARD ALL INFORMATION THAT WAS REPORTED IN THE INITIAL MDR FOR REPORT NUMBER 3004753838-2018-112266 AS THIS IS A DUPLICATE REPORT. THIS CUSTOMER COMPLAINT HAS BEEN PREVIOUSLY REPORTED IN REPORT NUMBER 3004753838-2018-114153.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT EXPERIENCED ADVERSE EVENTS ON DIFFERENT DAYS WITH THE SAME DEVICE. THE FOLLOWING REPORTS ARE SUBMITTED. (B)(4). USED FOR NO TERM AVAILABLE FOR DEVICE OPERATED WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON (B)(4) 2018, THAT ON (B)(6) 2018, A LOSS OF CONNECTION OCCURRED. NO ADDITIONAL EVENT INFORMATION IS AVAILABLE. DATA WAS PROVIDED FOR EVALUATION. LOSS OF CONNECTION WAS CONFIRMED, HOWEVER THE DEVICE OPERATED WITHIN SPECIFICATION. A ROOT CAUSE COULD NOT BE DETERMINED..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743562 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR PQF DEXCOM, INC. 9438-06 6007574

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR