BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 6495697 · Received April 14, 2017

    Report

    Report Number
    3004753838-2017-35183
    Event Type
    Malfunction
    Date Received
    April 14, 2017
    Date of Event
    March 20, 2017
    Report Date
    March 20, 2017
    Manufacturer
    DEXCOM, INC.
    Product Code
    PQF
    UDI-DI
    10386270000221
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE G5 SYSTEM IS ASSOCIATED WITH PRODUCT CODE PQF.

    Description of Event or Problem · 1

    A TRANSMITTER DEVICE (LOT #6000920, SERIAL # (B)(4)) NOT THE ALLEGED PRODUCT AT FAULT WAS RETURNED. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. A VOLTAGE TEST WAS PERFORMED AND IT PASSED. A PAIRING TEST WAS PERFORMED AND PASSED. FUNCTIONAL TESTING WAS PERFORMED AND THERE WAS NO FAILURE DETECTED. PREVIOUSLY, DATA WAS PROVIDED FOR EVALUATION. THE REPORTED EVENT OF LOSS OF CONNECTION WAS CONFIRMED VIA DATA. A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON (B)(6) 2017 THAT ON (B)(6) 2017, PATIENT EXPERIENCED A LOSS OF CONNECTION BETWEEN THE TRANSMITTER AND SMART DEVICE. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. DATA WAS PROVIDED FOR EVALUATION. THE REPORTED LOSS OF CONNECTION WAS CONFIRMED VIA DATA. A ROOT CAUSE COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276189 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR PQF DEXCOM, INC. 9438-06 5212488 10386270000221

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR