BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3004753838-2018-143207

    MDR report key: 8082545 · Received November 17, 2018

    Report

    Report Number
    3004753838-2018-143207
    Event Type
    Malfunction
    Date Received
    November 17, 2018
    Date of Event
    October 23, 2018
    Report Date
    March 26, 2019
    PMA / PMN Number
    P170031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    UPON COMPLETION OF DATA INVESTIGATION THE REPORTED ISSUE WAS CONFIRMED. THE PROBABLE CAUSE WAS THE TRANSMITTER AND APP WERE UNABLE TO ESTABLISH A CONNECTION.

    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 . IT WAS REPORTED THAT THE OPERATING SYSTEM FOR THE SMART DEVICE WAS NOT A SUPPORTED SYSTEM. LABELING INDICATES THAT THE DEXCOM CGM APPLICATION IS ONLY COMPATIBLE FOR SELECT DEVICES AND OPERATING SYSTEMS. 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.

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR