BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3004753838-2018-080146

    MDR report key: 7707875 · Received July 20, 2018

    Report

    Report Number
    3004753838-2018-080146
    Event Type
    Malfunction
    Date Received
    July 20, 2018
    Date of Event
    June 6, 2018
    Report Date
    June 27, 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, THE RECEIVER HAD NO AUDIO OUTPUT. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. NO PRODUCT WAS PROVIDED FOR EVALUATION. THE COMPLAINT CONFIRMATION OF THE RECEIVER HAVING NO AUDIO OUTPUT COULD NOT BE DETERMINED. A PROBABLE CAUSE COULD NOT BE DETERMINED.

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR