BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 6478562 · Received April 10, 2017

    Report

    Report Number
    3004753838-2017-32810
    Event Type
    Malfunction
    Date Received
    April 10, 2017
    Date of Event
    February 13, 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 DID NOT OBSERVE ERRORS IN THE LOG. THE CUSTOMER COMPLAINT WAS NOT CONFIRMED. 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, 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
    257251 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