BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 7892328 · Received September 19, 2018

    Report

    Report Number
    3004753838-2018-110606
    Event Type
    Malfunction
    Date Received
    September 19, 2018
    Date of Event
    August 20, 2018
    Report Date
    August 22, 2018
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). MODEL #/CATALOG #/UDI # - CORRECTION "9438-05, STT-GL-004, (B)(4)".

    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 OR PATIENT INFORMATION IS AVAILABLE. DATA WAS PROVIDED FOR EVALUATION. LOSS OF CONNECTION WAS CONFIRMED. THE ROOT CAUSE WAS DETERMINED TO BE THE TRANSMITTER AND APP WERE UNABLE TO ESTABLISH A CONNECTION.

    Description of Event or Problem · 1

    THE COMPLAINT TRANSMITTER DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. A VOLTAGE TEST WAS PERFORMED AND IT FAILED. PREVIOUSLY, DATA WAS EVALUATED AND IT CONFIRMED THE CUSTOMER COMPLAINT. THE REPORTED EVENT OF LOSS OF CONNECTION WAS CONFIRMED. THE ROOT CAUSE WAS DETERMINED TO BE THE TRANSMITTER AND APP WERE UNABLE TO ESTABLISH A CONNECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729134 DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR MDS DEXCOM, INC. 9438-06 6006925

    Patients

    Seq Age Sex Outcome Treatment
    1