BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 5992744 · Received October 1, 2016

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    Report

    Report Number
    3004753838-2016-92620
    Event Type
    Malfunction
    Date Received
    October 1, 2016
    Date of Event
    September 11, 2016
    Report Date
    September 12, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000019
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON 09/12/2016, THAT ON (B)(6) 2016, THERE WAS A CONTINUOUS GLUCOSE MONITORING (CGM) INACCURACY COMPARED TO BLOOD GLUCOSE (BG) METER THAT OCCURRED . THE SENSOR WAS INSERTED ON THE ABDOMEN, ON (B)(6) 2016. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. THE RECEIVER DATA LOG WAS REVIEWED ON 09/19/2016. THE COMPLAINT OF INACCURATE CGM VALUES WAS CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643936 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR MDS DEXCOM, INC. 9500-27 5209828 00386270000019

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR