BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 8621290 · Received May 17, 2019

    Report

    Report Number
    3004753838-2019-042818
    Event Type
    Malfunction
    Date Received
    May 17, 2019
    Date of Event
    April 23, 2019
    Report Date
    May 17, 2019
    Manufacturer
    DEXCOM, INC.
    Product Code
    PQF
    UDI-DI
    10386270000221
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LOSS OF CONNECTION OCCURRED. NO DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE ISSUE WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414140 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR PQF DEXCOM, INC. 9438-06 7250053 10386270000221

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR