BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3004753838-2019-021176

    MDR report key: 8368235 · Received February 25, 2019

    Report

    Report Number
    3004753838-2019-021176
    Event Type
    Malfunction
    Date Received
    February 25, 2019
    Date of Event
    February 5, 2019
    Report Date
    February 21, 2019
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 PAIRING FAILURE BETWEEN TRANSMITTER AND SMART DEVICE OCCURRED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. NO PRODUCT WAS PROVIDED FOR EVALUATION. DATA WAS PROVIDED FOR EVALUATION. DATA REVIEW DID NOT CONFIRM THE REPORTED EVENT OF PAIRING FAILURE. A ROOT CAUSE COULD NOT BE DETERMINED VIA DATA. THE REPORTED ISSUE OF PAIRING FAILURE IS REPORTABLE BASED ON THE FINDING OF PERMANENT CONNECTION LOSS.

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR