BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 5455286 · Received February 23, 2016

    Report

    Report Number
    3004753838-2016-01163
    Event Type
    Malfunction
    Date Received
    February 23, 2016
    Date of Event
    January 27, 2016
    Report Date
    January 27, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000224
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE RECEIVER (PART NUMBER STK-CR-PNK/SERIAL NUMBER (B)(4)/LOT NUMBER 5201376), BEING USED WITH THE TRANSMITTER WAS RETURNED FOR EVALUATION. THE RECEIVER WAS VISUALLY INSPECTED AND "CALL TECH SUPPORT" ERROR WAS OBSERVED ON THE SCREEN. THE DATA LOG COULD NOT BE RETRIEVED AND FUNCTIONAL TESTING COULD NOT BE PERFORMED BECAUSE OF THE "CALL TECH SUPPORT" ERROR. THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED WITH THE RECEIVER BECAUSE IT COULD NOT BE DETERMINED IF ANY ERROR OCCURRED ON THE DATE OF EVENT. HOWEVER, THE COMPLAINT TRANSMITTER WAS ALSO RETURNED FOR EVALUATION. THE TRANSMITTER WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. FUNCTIONAL TESTING WAS PERFORMED AND THE TEST FAILED. THE CUSTOMER COMPLAINT WAS CONFIRMED. THE ROOT CAUSE WAS DETERMINED TO BE A DEFECTIVE TRANSMITTER.

    Description of Event or Problem · 1

    PATIENT'S FATHER CONTACTED DEXCOM ON (B)(6) 2016 TO REPORT THAT ON (B)(6) 2016, THE G5 TRANSMITTER WOULD NOT PAIR WITH THE G5 APPLICATION. THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, THE DATA LOG WAS PROVIDED BY THE PATIENT. THE DATA WAS REVIEWED BUT COULD NOT CONFIRM THE REPORT OF TRANSMITTER NOT PAIRING WITH THE G5 APPLICATION AS THE DATES OF DATA SENT WERE NOT INCLUSIVE OF THE ISSUE DATE RANGE. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111088 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9438-06 5207842 00386270000224

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR