BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3004753838-2018-143567

    MDR report key: 8082544 · Received November 17, 2018

    Report

    Report Number
    3004753838-2018-143567
    Event Type
    Malfunction
    Date Received
    November 17, 2018
    Date of Event
    October 22, 2018
    Report Date
    March 27, 2019
    PMA / PMN Number
    P170031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    COM-(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. NO PRODUCT WAS PROVIDED FOR EVALUATION; HOWEVER, DATA HAS BEEN RECEIVED FOR INVESTIGATION. A FOLLOW-UP WILL BE SUBMITTED UPON COMPLETION OF DATA INVESTIGATION. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    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. LOSS OF CONNECTION WAS CONFIRMED. THE PROBABLE CAUSE WAS THE MOBILE DEVICE UPDATED ITS OPERATING SYSTEM WHICH CLOSED THE APP. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR