BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 5950723 · Received September 14, 2016

    Report

    Report Number
    3004753838-2016-62204
    Event Type
    Malfunction
    Date Received
    September 14, 2016
    Date of Event
    August 22, 2016
    Report Date
    August 22, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000224
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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) 2016 THAT ON (B)(6) 2016, THE PATIENT EXPERIENCED A LOSS OF CONNECTION BETWEEN THE TRANSMITTER AND THE RECEIVER. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. 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

    THE RECEIVER (B)(4)/LOT NUMBER 5213256) BEING USED WITH THE TRANSMITTER WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. FUNCTIONAL TESTING WAS PERFORMED AND THERE WAS NO FAILURE DETECTED RELATED TO THE COMPLAINT. A PAIRING TEST WAS PERFORMED WITH A KNOWN GOOD TRANSMITTER AND PASSED. A REVIEW OF THE DOWNLOADED RECEIVER LOG CONFIRMED THE REPORTED EVENT OF LOSS OF CONNECTION. A 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. VOLTAGE TESTING WAS PERFORMED AND THE TEST FAILED. THERE WAS NO SHARED DATA LOG AVAILABLE FOR REVIEW. THE REPORTED EVENT OF LOSS OF CONNECTION WAS NOT CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600314 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR MDS DEXCOM, INC. 9438-06 5214600 00386270000224

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR