BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 7522001 · Received May 17, 2018

    Report

    Report Number
    3004753838-2018-053171
    Event Type
    Malfunction
    Date Received
    May 17, 2018
    Date of Event
    March 10, 2018
    Report Date
    April 18, 2018
    Manufacturer
    DEXCOM, INC.
    Product Code
    PQF
    UDI-DI
    10386270000221
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DESCRIBE EVENT OR PROBLEM ¿ ADDITIONAL, DEVICE AVAILABILITY- CORRECTION, ADDITIONAL INFORMATION/CORRECTION, EVENT PROBLEM AND EVALUATION CODES - ADDITIONAL.

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON 04/18/2018, THAT ON (B)(6) 2018, A LOSS OF CONNECTION OCCURRED. THE PRODUCT HAS BEEN RECEIVED FOR EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION HAS BEEN COMPLETED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON 04/18/2018, THAT ON (B)(6) 2018, A LOSS OF CONNECTION OCCURRED. DATA WAS PROVIDED FOR EVALUATION. THE REPORTED ISSUE WAS CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363582 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR PQF DEXCOM, INC. 9438-06 6005783 10386270000221

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR