BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 6192966 · Received December 21, 2016

    Report

    Report Number
    3004753838-2016-89270
    Event Type
    Malfunction
    Date Received
    December 21, 2016
    Date of Event
    November 25, 2016
    Report Date
    November 25, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000224
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE TRANSMITTER WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED AND NO DEFECTS WERE FOUND. VOLTAGE TESTING WAS PERFORMED AND THE TEST FAILED, THE TRANSMITTER HAS NO VOLTAGE. A REVIEW OF THE TRANSMITTER LOG CONFIRMED THE REPORTED EVENT OF A TRANSMITTER FAILED ERROR. THE ROOT CAUSE WAS COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON (B)(6) 2016 THAT ON (B)(6) 2016, PATIENT EXPERIENCED A FAILED TRANSMITTER ERROR. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. THE DEVICE HAS BEEN RECEIVED FOR INVESTIGATION. A FOLLOW-UP WILL BE SUBMITTED UPON COMPLETION OF DEVICE INVESTIGATION. DATA WAS PROVIDED FOR EVALUATION. THE REPORTED EVENT OF A FAILED TRANSMITTER ERROR WAS CONFIRMED VIA DATA. A ROOT CAUSE COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844657 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR MDS DEXCOM, INC. 9438-06 5214648 00386270000224

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR