BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 7237171 · Received February 2, 2018

    Report

    Report Number
    3004753838-2018-011753
    Event Type
    Malfunction
    Date Received
    February 2, 2018
    Date of Event
    December 24, 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/RECEIVER. 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
    79345 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