BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 6028242 · Received October 13, 2016

    Report

    Report Number
    3004753838-2016-23413
    Event Type
    Malfunction
    Date Received
    October 13, 2016
    Date of Event
    September 16, 2016
    Report Date
    September 16, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CLINICAL SITE WAS NOT ABLE TO CONFIRM TRANSMITTER AT FAULT. THE TRANSMITTER AT FAULT WAS REPORTED TO BE ONE OF THE FOLLOWING: TRANSMITTER 1: STT-GF-004; (B)(4); LOT#5208788; MFR DATE = 01/26/2016. TRANSMITTER 2: STT-GF-001; (B)(4); LOT# 5210234; MFR DATE = 01/29/2016.

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON (B)(6) 2016, THAT ON (B)(6) 2016, LOSS OF CONNECTION BETWEEN THE TRANSMITTER AND RECEIVER OCCURRED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678699 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR MDS DEXCOM, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1