BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 6078498 · Received November 4, 2016

    Report

    Report Number
    3004753838-2016-67664
    Event Type
    Malfunction
    Date Received
    November 4, 2016
    Date of Event
    October 14, 2016
    Report Date
    October 14, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000019
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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 INTO THE ABDOMEN ON (B)(6) 2016. REPORTEDLY, THE PATIENT DID NOT CALIBRATE AFTER THE INACCURACY. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. DATA WAS PROVIDED FOR REVIEW; HOWEVER, INACCURATE CGM VALUES COULD NOT BE FOUND. A ROOT CAUSE COULD NOT BE DETERMINED VIA DATA. 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
    730563 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR MDS DEXCOM, INC. 9500-27 ASKU 00386270000019

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR