BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 7273529 · Received February 15, 2018

    Report

    Report Number
    3004753838-2018-111763
    Event Type
    Malfunction
    Date Received
    February 15, 2018
    Date of Event
    August 9, 2018
    Report Date
    August 24, 2018
    Manufacturer
    DEXCOM, INC.
    Product Code
    PQF
    UDI-DI
    20386270000228
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTION. REPORT SUBMITTED IN ERROR. PLEASE SEE MFR 3004753838-2017-111763, FOLLOW-UP NUMBER 001.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE TRANSMITTER WAS RETURNED FOR EVALUATION. AN EXTERIOR VISUAL INSPECTION WAS PERFORMED AND PASSED. A VOLTAGE TEST WAS PERFORMED AND THE DEVICE HELD NO VOLTAGE; THEREFORE FUNCTIONAL TESTING COULD NOT BE PERFORMED. NO SHARE LOG DATA WAS AVAILABLE FOR REVIEW. THE CONFIRMATION OF THE PROBLEM WAS UNDETERMINED. THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON 08/24/2018, THAT ON (B)(6) 2018, A LOSS OF CONNECTION OCCURRED. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED, AND NO DEFECT WAS FOUND. VOLTAGE TESTING WAS PERFORMED AND PASSED. A PAIRING TEST WAS PERFORMED AND PASSED. FUNCTIONAL TESTING WAS PERFORMED AND THERE WAS NO FAILURE DETECTED RELATED TO THE COMPLAINT. A REVIEW OF THE DATA LOG WAS PERFORMED AND PASSED. THE REPORTED ISSUE WAS NOT 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
    119249 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR PQF DEXCOM, INC. 9438-06 6007726 20386270000228

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR