BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 6210701 · Received December 28, 2016

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    Report

    Report Number
    3004753838-2016-88591
    Event Type
    Malfunction
    Date Received
    December 28, 2016
    Date of Event
    December 4, 2016
    Report Date
    December 6, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000019
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    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 UPPER BUTTOCKS 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858983 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR MDS DEXCOM, INC. 9500-27 5216093 00386270000019

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR