BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 8648175 · Received May 28, 2019

    Report

    Report Number
    3004753838-2019-45236
    Event Type
    Malfunction
    Date Received
    May 28, 2019
    Date of Event
    January 16, 2019
    Report Date
    May 28, 2019
    Manufacturer
    DEXCOM, INC.
    Product Code
    PQF
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DESCRIBE EVENT OR PROBLEM - CORRECTION " THE LOG WAS DOWNLOADED AND REVIEWED FINDING AN ERROR RELATED TO THE COMPLAINT. THE ALLEGATION WAS CONFIRMED. "

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A REVIEW OF THE SHARE LOGS WAS PERFORMED AND A PAIRING FAILED WAS NOT FOUND WITHIN THE INVESTIGATION WINDOW. THE ALLEGATION WAS NOT CONFIRMED.

    Description of Event or Problem · 1

    THE PRODUCT WAS EVALUATED. THE DEVICE WAS VISUALLY INSPECTED AND PASSED. A VOLTAGE TEST WAS PERFORMED, AND IT FAILED. THE LOG WAS DOWNLOADED AND REVIEWED FINDING AN ERROR RELATED TO THE COMPLAINT. THE ALLEGATION WAS CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, A PAIRING FAILURE OCCURRED. DATA WAS EVALUATED AND THE ALLEGATION WAS NOT CONFIRMED BUT A FAILED TRANSMITTER ERROR WAS CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. PRODUCT HAS BEEN RECEIVED BUT IS PENDING EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION. THE REPORTED EVENT OF A PAIRING FAILURE IS REPORTABLE BASED ON THE FINDING OF A FAILED TRANSMITTER ERROR. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440751 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR PQF DEXCOM, INC. 9438-06 7244262

    Patients

    Seq Age Sex Outcome Treatment
    1