BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 7237047 · Received February 2, 2018

    Report

    Report Number
    3004753838-2018-011714
    Event Type
    Malfunction
    Date Received
    February 2, 2018
    Date of Event
    December 18, 2017
    Report Date
    March 5, 2018
    Manufacturer
    DEXCOM, INC.
    Product Code
    PQF
    UDI-DI
    10386270000221
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT EXPERIENCED ADVERSE EVENTS ON DIFFERENT DAYS WITH THE SAME DEVICE. THE FOLLOWING REPORTS ARE BEING SUBMITTED: 180104-000349, 180201-000685, 180201-000698, 180201-000709, 180201-000718, 180201-000731, 180201-000738, 171220-000553, 180104-000401, 180201-000630, 180201-000647, 180201-000666, 180104-000429, 180201-000762, 180201-000775, 180201-000784, 180201-000792, 180201-000800, 180201-000809, 180104-000447, 180201-000830.

    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 BETWEEN THE TRANSMITTER AND SMART DEVICE. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. DATA WAS RETURNED AND EVALUATED. THE REPORTED EVENT OF A LOSS OF CONNECTION WAS CONFIRMED VIA DATA. A PROBABLE CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON (B)(4) 2018 THAT ON (B)(6) 2018, A LOSS OF CONNECTION BETWEEN THE TRANSMITTER AND SMART DEVICE. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. A PAIRING TEST WAS PERFORMED WITH A KNOWN GOOD TRANSMITTER AND FAILED. VOLTAGE TESTING WAS PERFORMED AND PASSED. A REVIEW OF THE DOWNLOADED DATA LOG CONFIRMED THE REPORTED EVENT OF LOSS OF CONNECTION. A ROOT CAUSE COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80590 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR PQF DEXCOM, INC. 9438-06 6003484 10386270000221

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR