BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 6478558 · Received April 10, 2017

    Report

    Report Number
    3004753838-2017-30735
    Event Type
    Malfunction
    Date Received
    April 10, 2017
    Date of Event
    March 6, 2017
    Report Date
    March 15, 2017
    Manufacturer
    DEXCOM, INC.
    Product Code
    PQF
    UDI-DI
    00386270000002
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    THE TRANSMITTER (SERIAL NUMBER (B)(4)/LOT NUMBER 6000876) BEING USED AT THE TIME OF EVENT WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED AND NO DEFECTS WERE FOUND. VOLTAGE TESTING WAS PERFORMED AND THE TRANSMITTER HAD VOLTAGE. FUNCTIONAL TESTING AND A PAIRING TEST WAS PERFORMED AND THE TESTS FAILED; HOWEVER, IT IS UNRELATED TO THE CUSTOMER COMPLAINT. A REVIEW OF THE SHARED DATA LOG OBSERVED AN ERROR IN THE LOG. THE CUSTOMER COMPLAINT WAS CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON 03/15/2017, THAT ON (B)(6) 2017, THE G5 MOBILE APPLICATION SHUTS OFF UNEXPECTEDLY. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. DATA LOG WAS REVIEWED FOR EVALUATION ON 03/31/2017. COMPLAINT FOR AN UNEXPECTED G5 MOBILE APPLICATION SHUT-OFF WAS CONFIRMED. THE ROOT CAUSE WAS DETERMINED TO BE A STRUCTURED QUERY LANGUAGE ERROR (SQL), POST INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257249 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR PQF DEXCOM, INC. NA NA 00386270000002

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR