BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 5976850 · Received September 26, 2016

    Report

    Report Number
    3004753838-2016-03994
    Event Type
    Malfunction
    Date Received
    September 26, 2016
    Date of Event
    August 31, 2016
    Report Date
    August 31, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON (B)(6) 2016 THAT A LOSS OF CONNECTION BETWEEN THE TRANSMITTER AND RECEIVER OCCURRED ON (B)(6) 2016. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED. PRODUCT DATA WAS RETURNED FOR EVALUATION. DATA WAS REVIEWED ON 09/12/2016. THE REPORTED EVENT OF LOSS OF CONNECTION WAS NOT CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE COMPLAINT TRANSMITTER WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. FUNCTIONAL TESTING AND A PAIRING TEST COULD NOT BE PERFORMED BECAUSE THE TRANSMITTER HAS NO VOLTAGE. THE CUSTOMER COMPLAINT WAS UNABLE TO BE CONFIRMED THROUGH TRANSMITTER TESTING. ADDITIONALLY, THE RECEIVER (PART NUMBER STK-GF-109/SERIAL NUMBER (B)(4)/LOT NUMBER 5210540) BEING USED AT THE TIME OF EVENT WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND "CALL LOCA DISTRIBUTOR ERROR 121" ERROR WAS OBSERVED ON THE SCREEN. THE DATA LOG COULD NOT BE RETRIEVED AND FUNCTIONAL TESTING COULD NOT BE PERFORMED BECAUSE OF THE "CALL LOCA DISTRIBUTOR ERROR 121" ERROR. THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED BECAUSE IT COULD NOT BE DETERMINED IF ANY OUT OF RANGE OCCURRED ON THE DATE OF EVENT. THE ROOT CAUSE COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627867 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR MDS DEXCOM, INC. 9438-06 5211651

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR