BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3004753838-2018-121421

    MDR report key: 7961674 · Received October 12, 2018

    Report

    Report Number
    3004753838-2018-121421
    Event Type
    Malfunction
    Date Received
    October 12, 2018
    Date of Event
    September 16, 2018
    Report Date
    September 16, 2018
    PMA / PMN Number
    P170031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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 THE DISPLAY DEVICE SHOWED A TRANSMITTER FAILED ERROR ON (B)(6) 2018. DATA WAS RETURNED AND EVALUATED. THE REPORTED EVENT OF A TRANSMITTER FAILED ERROR WAS CONFIRMED VIA DATA. THE PROBABLE CAUSE WAS DETERMINED TO BE A LOW TRANSMITTER BATTERY THAT LED TO A TRANSMITTER FAILURE. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR