BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 5680702 · Received May 25, 2016

    Report

    Report Number
    3004753838-2016-60093
    Event Type
    Malfunction
    Date Received
    May 25, 2016
    Date of Event
    May 2, 2016
    Report Date
    May 2, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000224
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PATIENT'S FATHER CONTACTED DEXCOM ON (B)(6) 2016 TO REPORT A TRANSMITTER FAILED ERROR THAT OCCURRED ON (B)(6) 2016. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED. PRODUCT DATA WAS RETURNED FOR EVALUATION. DATA WAS REVIEWED ON 05/20/2016. THE REPORTED EVENT OF TRANSMITTER FAILED ERROR WAS CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE TRANSMITTER WAS RETURNED FOR EVALUATION. EXTERIOR VISUAL INSPECTION WAS PERFORMED AND THE TRANSMITTER PASSED. VOLTAGE TESTING WAS PERFORMED AND THE TRANSMITTER FAILED AS IT HAS NO VOLTAGE. DATA LOG REVIEW WAS REPEATED AT TIME OF DEVICE EVALUATION AND DID NOT CONFIRM THE REPORTED EVENT OF FAILED TRANSMITTER ERROR. A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    DUPONT RE-EVALUATION A OF THE DEVICE, VOLTAGE TESTING WAS PERFORMED AND THE TEST FAILED, THE TRANSMITTER HAS NO VOLTAGE. A REVIEW OF THE SHARED LOG CONFIRMED THE REPORTED EVENT OF A TRANSMITTER FAILED ERROR. THE ROOT CAUSE WAS COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333928 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9438-06 5207750 00386270000224

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR