BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 7741635 · Received August 1, 2018

    Report

    Report Number
    3004753838-2018-078471
    Event Type
    Malfunction
    Date Received
    August 1, 2018
    Date of Event
    June 26, 2018
    Report Date
    September 18, 2018
    Manufacturer
    DEXCOM, INC.
    Product Code
    PFQ
    UDI-DI
    10386270000221
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON (B)(4) 2018, THAT ON (B)(6) 2018, A PAIRING FAILURE BETWEEN THE TRANSMITTER AND SMART DEVICE AND/OR RECEIVER OCCURRED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. DATA WAS PROVIDED FOR EVALUATION. DATA REVIEW CONFIRMED THE REPORTED EVENT OF PAIRING FAILURE. THE ROOT CAUSE WAS DETERMINED TO BE A FAILED TRANSMITTER ERROR. REPORTED ISSUE OF PAIRING FAILURE IS REPORTABLE BASED ON THE FINDING OF TRANSMITTER FAILURE ERROR.

    Description of Event or Problem · 1

    THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. AN EXTERIOR PHYSICAL VISUAL INSPECTION WAS PERFORMED AND THE DEVICE PASSED. THE TRANSMITTER VOLTAGE WAS TESTED AND FAILED AT 0VDC. THE CLOUD/SHARE DATA WAS AVAILABLE. TRANSMITTER FATAL ERROR WAS FOUND IN SHARE LOG BUT NOT RELATED TO COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581910 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR PFQ DEXCOM, INC. 9438-06 6006057 10386270000221

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR