BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 6095882 · Received November 11, 2016

    Report

    Report Number
    3004753838-2016-87685
    Event Type
    Malfunction
    Date Received
    November 11, 2016
    Date of Event
    October 14, 2016
    Report Date
    October 14, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000019
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON (B)(4) 2016 THAT ON (B)(6) 2016, THE PATIENT EXPERIENCED A STATIC ZAP WHILE WEARING HER SENSOR. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION OF THE SENSOR WAS PERFORMED, WHICH DID NOT CONFIRM THE CUSTOMER COMPLAINT. THE REPORTED EVENT OF A STATIC ZAP WHILE WEARING THE SENSOR WAS NOT CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED. THE TRANSMITTER (PART NUMBER STT-GF-001/SERIAL NUMBER (B)(4)/LOT NUMBER 5212245), BEING USED WITH THE COMPLAINT SENSOR, WAS RETURNED ON 11/07/2016. FUNCTIONAL AND PAIRING TESTING WAS PERFORMED AND THERE WAS NO FAILURE DETECTED. THE SHARE DATA LOG WAS REVIEWED AND NO ERRORS WERE OBSERVED. THE REPORTED EVENT OF A STATIC ZAP WHILE WEARING THE SENSOR WAS NOT CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747281 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR MDS DEXCOM, INC. 9500-27 5215260 00386270000019

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR