BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 6138886 · Received December 1, 2016

    Report

    Report Number
    3004753838-2016-56732
    Event Type
    Malfunction
    Date Received
    December 1, 2016
    Date of Event
    November 8, 2016
    Report Date
    November 9, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000224
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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) 2016 THAT ON (B)(6) 2016, PATIENT EXPERIENCED A LOSS OF CONNECTION BETWEEN THE TRANSMITTER AND SMART DEVICE. REPORTEDLY, THE PATIENT USED AN ALTERNATE INSERTION SITE. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. DATA WAS PROVIDED FOR EVALUATION. THE REPORTED LOSS OF CONNECTION WAS CONFIRMED VIA DATA. A ROOT CAUSE COULD NOT BE DETERMINED. LABELING INDICATES: DO NOT INSERT THE SENSOR COMPONENT OF THE DEXCOM G5 MOBILE SYSTEM IN A SITE OTHER THAN THE BELLY/ABDOMEN (AGES 2 YEARS AND OLDER) OR THE UPPER BUTTOCKS (AGES 2 TO 17 YEARS). THE PLACEMENT AND INSERTION OF THE SENSOR COMPONENT OF THE DEXCOM G5 MOBILE SYSTEM IS NOT APPROVED FOR OTHER SITES. IF PLACED IN OTHER AREAS, THE DEXCOM G5 MOBILE SYSTEM MAY NOT FUNCTION PROPERLY.

    Description of Event or Problem · 1

    THE COMPLAINT DEVICE 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. THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED WITH THE TRANSMITTER TESTING; HOWEVER, A REVIEW OF THE SHARED RECEIVER LOG CONFIRMED THE REPORTED EVENT OF LOSS OF CONNECTION. A ROOT CAUSE COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790298 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR MDS DEXCOM, INC. 9438-06 5216394 00386270000224

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR UNKNOWN SMART PHONE