BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 6592650 · Received May 25, 2017

    Report

    Report Number
    3004753838-2017-44587
    Event Type
    Malfunction
    Date Received
    May 25, 2017
    Date of Event
    April 28, 2017
    Report Date
    April 28, 2017
    Manufacturer
    DEXCOM, INC.
    Product Code
    PQF
    UDI-DI
    10386270000221
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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) 2017 THAT ON (B)(6) 2017, PATIENT EXPERIENCED A FAILED TRANSMITTER ERROR. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. THE DEVICE HAS BEEN RECEIVED FOR INVESTIGATION. A FOLLOW-UP WILL BE SUBMITTED UPON COMPLETION OF DEVICE INVESTIGATION.

    Description of Event or Problem · 1

    A TRANSMITTER DEVICE (LOT#6000816 , SERIAL#(B)(4)) WAS RETURNED THAT IS NOT THE ALLEGED PRODUCT AT FAULT. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. VOLTAGE TESTING WAS PERFORMED AND THE TEST FAILED. THE REPORTED EVENT OF TRANSMITTER FAILED ERROR WAS NOT CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. FUNCTIONAL TESTING WAS PERFORMED AND FAILED. A PAIRING TEST WAS PERFORMED WITH A KNOWN GOOD TRANSMITTER AND FAILED. A VOLTAGE TEST WAS PERFORMED AND PASSED. THERE WAS NO DATA LOG AVAILABLE TO CONFIRM THE REPORTED EVENT OF A TRANSMITTER FAILED ERROR. A ROOT CAUSE COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371181 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR PQF DEXCOM, INC. 9438-06 6001788 10386270000221

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR