BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 7817857 · Received August 27, 2018

    Report

    Report Number
    3004753838-2018-097901
    Event Type
    Malfunction
    Date Received
    August 27, 2018
    Date of Event
    May 25, 2018
    Report Date
    October 12, 2018
    Manufacturer
    DEXCOM, INC.
    Product Code
    PQF
    UDI-DI
    10386270000221
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 08/03/2018 THAT ON (B)(6) 2018, A LOSS OF CONNECTION OCCURRED. DATA WAS RETURNED AND EVALUATED. THE REPORTED EVENT OF A LOSS OF CONNECTION WAS CONFIRMED VIA DATA. THE PROBABLE CAUSE WAS DETERMINED TO BE NO COMMUNICATION ¿ GAP IN LOGS.

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON 08/03/2018 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 SHARE LOGS WAS PERFORMED AND NO DATA ON SHARE TOOL IN RANGE OF INCIDENT DATE. THE PROBABLE CAUSE WAS DETERMINED TO BE NO COMMUNICATION ¿ GAP IN LOGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661535 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR PQF DEXCOM, INC. 9438-06 6004195 10386270000221

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR