BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 6119453 · Received November 21, 2016

    Report

    Report Number
    3004753838-2016-29811
    Event Type
    Malfunction
    Date Received
    November 21, 2016
    Date of Event
    November 1, 2016
    Report Date
    November 1, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000019
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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 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. IT WAS REPORTED THAT CALIBRATION WAS NOT PERFORMED AFTER EXPERIENCING INACCURACIES. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. THE RECEIVER DATA LOG WAS REVIEWED ON 11/17/2016. THE COMPLAINT OF INACCURATE CGM VALUES WAS CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED. LABELING INDICATES: IF THE CGM VALUES ARE OUTSIDE THE 20/20 RANGE, CALIBRATE AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767934 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR MDS DEXCOM, INC. 9500-27 5209487 00386270000019

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR (B)(6)