BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3004753838-2018-161724

    MDR report key: 8200013 · Received December 27, 2018

    Report

    Report Number
    3004753838-2018-161724
    Event Type
    Malfunction
    Date Received
    December 27, 2018
    Date of Event
    December 11, 2018
    Report Date
    December 11, 2018
    PMA / PMN Number
    DEN170088
    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

    DEXCOM WAS MADE AWARE ON (B)(4) 2018, THAT ON (B)(6) 2018, A LOSS OF CONNECTION OCCURRED. DATA WAS PROVIDED FOR EVALUATION. LOSS OF CONNECTION WAS CONFIRMED, HOWEVER, THE DEVICE OPERATED WITHIN SPECIFICATION. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR