BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 5719298 · Received June 11, 2016

    Report

    Report Number
    3004753838-2016-44372
    Event Type
    Malfunction
    Date Received
    June 11, 2016
    Date of Event
    May 15, 2016
    Report Date
    May 15, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000231
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PATIENT CONTACT DEXCOM ON 05/15/2016 TO REPORT A LOSS OF CONNECTION BETWEEN THE TRANSMITTER AND RECEIVER THAT OCCURRED ON (B)(6) 2016. THE RECEIVER WAS UNABLE TO PAIR WITH THE FIRST TRANSMITTER. PATIENT PERFORMED A PAPERCLIP RESET AND THE ISSUE WAS NOT RESOLVED. ADVISED PATIENT TO USE ANOTHER TRANSMITTER AND THE TRANSMITTER WORKED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE DEVICE HAS BEEN RECEIVED FOR EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MDR, THE RECEIVER WAS NOT RETURNED FOR EVALUATION. THE TRANSMITTER (PART NUMBER STT-GF-001/SERIAL NUMBER (B)(4)/LOT NUMBER 5211575) WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. FUNCTIONAL TESTING WAS PERFORMED AND THERE WAS NO FAILURE DETECTED. A PAIRING TEST WAS PERFORMED AND THE TEST PASSED. THE REPORTED EVENT OF A LOSS OF CONNECTION WAS NOT CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373609 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. MT22719 5213196 00386270000231

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR