BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3004753838-2018-053075

    MDR report key: 7523191 · Received May 17, 2018

    Report

    Report Number
    3004753838-2018-053075
    Event Type
    Malfunction
    Date Received
    May 17, 2018
    Date of Event
    March 19, 2018
    Report Date
    April 19, 2018
    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).

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON (B)(4) 2018, THAT ON (B)(6) 2018, A LOSS OF CONNECTION OCCURRED. IT WAS DETERMINED THAT LOSS OF CONNECTION WAS RELATED TO THE MOBILE APPLICATION. DATA WAS PROVIDED FOR EVALUATION. THE REPORTED ISSUE WAS CONFIRMED. THE PROBABLE CAUSE WAS THE MOBILE DEVICE LOST POWER. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR