BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 6609707 · Received June 2, 2017

    Report

    Report Number
    3004753838-2017-38699
    Event Type
    Malfunction
    Date Received
    June 2, 2017
    Date of Event
    April 12, 2017
    Report Date
    May 2, 2017
    Manufacturer
    DEXCOM, INC.
    Product Code
    PQF
    UDI-DI
    10386270000221
    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).

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON (B)(6) 2017 THAT ON (B)(6) 2017, THE RECEIVER DISPLAYED AN ERROR MESSAGE FOR LOW TRANSMITTER BATTERY. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. DATA WAS PROVIDED FOR INVESTIGATION. THE REPORTED ALLEGATION WAS NOT FOUND VIA DATA, BUT A TRANSMITTER PERMANENT LOSS OF CONNECTION WAS CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED POST-INVESTIGATION. BASED ON THE INVESTIGATION RESULTS, THIS ISSUE HAS BEEN UPGRADED FROM NON-REPORTABLE TO REPORTABLE.

    Description of Event or Problem · 1

    A TRANSMITTER (SERIAL NUMBER (B)(4)/LOT NUMBER 6000794) 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 AND THE TEST PASSED. VOLTAGE TESTING WAS PERFORMED AND THE TRANSMITTER HAS VOLTAGE. A REVIEW OF THE DOWNLOADED DATA LOG DID NOT FIND ANY ERRORS RELATED TO THE CUSTOMER COMPLAINT. THE REPORTED EVENT OF A LOW TRANSMITTER BATTERY WAS NOT CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED. THE RETURNED DEVICE WAS NOT THE COMPLAINT PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390142 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR PQF DEXCOM, INC. 9438-06 6000794 10386270000221

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR