BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 7150244 · Received December 27, 2017

    Report

    Report Number
    3004753838-2017-110001
    Event Type
    Malfunction
    Date Received
    December 27, 2017
    Date of Event
    November 28, 2017
    Report Date
    November 28, 2017
    Manufacturer
    DEXCOM, INC.
    Product Code
    PQF
    UDI-DI
    10386270000221
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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)(4) 2017 THAT THE SMART DEVICE SHOWED A TRANSMITTER FAILED ERROR ON (B)(6) 2017 . NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. THE TRANSMITTER 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 COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. VOLTAGE TEST FAILED. SHARE LOG REVIEW SHOWED TRANSMITTER FAILURE ALERT IN LOG. THE COMPLAINT WAS CONFIRMED BECAUSE A TRANSMITTER ERROR ALERT IN THE CLOUD DATA THE REPORTED EVENT OF A FAILED TRANSMITTER ERROR WAS CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. 1. PROBLEM NOT CONFIRMED. INVESTIGATION SUMMARY:1. PERFORM EXTERIOR VISUAL INSPECTION: PASSED 2. VOLTAGE MEASUREMENT: FAILED 0.21 VDC 3. PERFORM PAIRING TEST WITH NORDIC BLUETOOTH DEVICE: PASSED 4. DATA AVAILABLE IN THE CLOUD\SHARE AND PERFORM REVIEW OF THIS DATA: YES - TRANSMITTER ERROR WAS NOT FOUND 5. PERFORM REVIEW OF THE BIN FILE: YES-TRANSMITTER ERROR WAS NOT FOUND FFA LAB PRODUCT AND DATA INVESTIGATION I. FFA LAB COULD NOT FIND\CONFIRM A TRANSMITTER FAILED ERROR WITHIN THE INVESTIGATION WINDOW USING THE DEXCOM SHARE SUPPORT TOOL. II. DURING THE DATA BASE BIN FILE INVESTIGATION IN THE LOG INFORMATION TAB - SHOWS THAT NO "BATT CRT" IN THE LOG INFORMATION COLUMN WAS NEVER FOUND AND THIS CONFIRMS THAT THE TRANSMITTER NEVER SENT THE "TRANSMITTER FAILED ERROR" OR "TRANSMITTER FATAL ERROR" MESSAGE TO THE SMART DEVICE AND\OR RECEIVER. PLEASE SEE THE ATTACHED FILE "FFA LAB PRODUCT AND DATA INVESTIGATION TX UNIT 413AYJ FOR SR-(B)(4)" III. CUSTOMER COMPLAINT CANNOT BE CONFIRMED WITH TRANSMITTER'S HARDWARE TEST RESULTS ROOT CAUSE:THE CUSTOMER ALLEGATION WAS NOT FOUND

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    927812 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR PQF DEXCOM, INC. 9438-06 6002976 10386270000221

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR