BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 5685991 · Received May 27, 2016

    Report

    Report Number
    3004753838-2016-44035
    Event Type
    Malfunction
    Date Received
    May 27, 2016
    Date of Event
    May 2, 2016
    Report Date
    May 3, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000224
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PATIENT'S FATHER CONTACT DEXCOM ON (B)(6) 2016 TO REPORT A LOSS OF CONNECTION BETWEEN THE TRANSMITTER AND RECEIVER THAT OCCURRED ON (B)(6) 2016. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    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 WAS NOT PROVIDED FOR REVIEW. THE REPORTED EVENT OF LOSS OF CONNECTION COULD NOT BE CONFIRMED WITH THE RETURNED TRANSMITTER. ADDITIONALLY, THE RECEIVER (PART NUMBER STR-GF-BLU/SERIAL NUMBER (B)(4)/LOT NUMBER 5210535) BEING USED AT THE TIME OF EVENT WAS RETURNED ON (B)(6) 2016. THE RETURNED RECEIVER WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. AN ATTEMPT TO TEST THE RECEIVER WAS MADE; HOWEVER, AN ERROR MESSAGE WAS DISPLAYING ON THE SCREEN. THE ERROR MESSAGE STOPS THE RECEIVER FROM COMMUNICATING AND FUNCTIONING. AS A RESULT, THE RECEIVER DATA LOG COULD NOT BE DOWNLOADED AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. PICTURES WERE TAKEN OF THE RECEIVER DISPLAY. THE REPORTED EVENT OF A LOSS OF CONNECTION COULD NOT BE CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340341 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9438-06 5209353 00386270000224

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR