BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 5796080 · Received July 14, 2016

    Report

    Report Number
    3004753838-2016-38728
    Event Type
    Malfunction
    Date Received
    July 14, 2016
    Date of Event
    May 18, 2016
    Report Date
    June 16, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PATIENT'S MOTHER CONTACTED DEXCOM ON (B)(6) 2016 TO REPORT THAT ON (B)(6) 2016, THE PATIENT EXPERIENCED NO DATA FOR AN UNKNOWN EXTENDED PERIOD OF TIME. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. THE COMPLAINT DEVICE WAS NOT RETURNED, BUT THE RECEIVER (S/N (B)(4)) THAT WAS USED WITH THE DEVICE HAS BEEN RECEIVED FOR EVALUATION ON (B)(6) 2016. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETE. THE DATA LOG WAS PROVIDED BY THE PATIENT. THE DATA WAS REVIEWED ON (B)(6) 2016 AND DID NOT CONFIRM THE REPORT OF NO DATA. THE SENSOR WAS INSERTED INTO THE ARM. THE PRODUCT LABELING INDICATES THAT SENSOR INSERTION IS NOT APPROVED IN SITES OTHER THAN THE BELLY/ABDOMEN (AGES 2 YEARS AND OLDER) OR THE UPPER BUTTOCKS (AGES 2 TO 17 YEARS).

    Description of Event or Problem · 1

    THE COMPLAINT DEVICE IS UNKNOWN; HOWEVER, A RECEIVER (PART NUMBER STR-GF-001/SERIAL NUMBER (B)(4)/LOT NUMBER 5213168) WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECTS WERE FOUND. FUNCTIONAL TESTING WAS PERFORMED AND THE TEST FAILED. A REVIEW OF THE DATA LOG DID NOT FIND ANY ERRORS RELATED TO THE CUSTOMER COMPLAINT. THE RECEIVER CASE WAS OPENED AND AN INTERIOR VISUAL INSPECTION FOUND MOISTURE DAMAGE. BECAUSE THE COMPLAINT DEVICE IS UNKNOWN, THE EVALUATION OF THE RECEIVER IS NOT RELEVANT TO THE COMPLAINT. THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448527 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. NI ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR