BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 6090652 · Received November 9, 2016

    Report

    Report Number
    3004753838-2016-93372
    Event Type
    Malfunction
    Date Received
    November 9, 2016
    Date of Event
    October 18, 2016
    Report Date
    October 18, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000224
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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, THERE WAS AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER. THE SENSOR WAS INSERTED AT THE BACK ON (B)(6) 2016. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. DATA WAS PROVIDED. REVIEW OF THE DATA LOG CONFIRMED THE REPORTED INACCURACY. A ROOT CAUSE COULD NOT BE DETERMINED VIA DATA. 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 TRANSMITTER WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED AND NO DEFECTS WERE FOUND. FUNCTIONAL TESTING AND A PAIRING TEST WAS PERFORMEC AND THE TESTS PASSED. THE REPORTED EVENT OF INACCURACIES WAS NOT CONFIRMED BECAUSE INFORMATION ABOUT INACCURACIES CANNOT BE OBTAINED FROM THE TRANSMITTER. A ROOT CAUSE COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739966 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR MDS DEXCOM, INC. 9438-06 5214642 00386270000224

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR