BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 4860766 · Received June 22, 2015

    Report

    Report Number
    3004753838-2015-16112
    Event Type
    Malfunction
    Date Received
    June 22, 2015
    Date of Event
    May 20, 2015
    Report Date
    May 27, 2015
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    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). THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION AND DATA WAS NOT PROVIDED; THEREFORE, THE REPORTED COMPLAINT OF INACCURACIES CANNOT BE CONFIRMED. IT WAS REPORTED THAT THE PATIENT DID NOT CALIBRATE ACCORDING TO THE USER'S GUIDE. IT SHOULD BE NOTED THAT THE DEXCOM G4® PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM USER'S GUIDE STATES: "DO NOT CALIBRATE IF YOUR BLOOD GLUCOSE IS CHANGING AT A SIGNIFICANT RATE, TYPICALLY MORE THAN 2 MG/DL PER MINUTE. DO NOT CALIBRATE WHEN YOUR RECEIVER SCREEN IS SHOWING THE RISING SINGLE ARROW OR DOUBLE ARROW, WHICH INDICATES THAT YOUR BLOOD GLUCOSE IS RISING 2-3 MG/DL/MIN OR MORE THAN 3 MG/DL/MIN. ALSO, DO NOT CALIBRATE WHEN YOUR RECEIVER SCREEN IS SHOWING THE FALLING SINGLE ARROW OR DOUBLE ARROW, WHICH INDICATES THAT YOUR BLOOD GLUCOSE IS FALLING 2-3 MG/DL/MIN OR MORE THAN 3 MG/DL/MIN. CALIBRATING DURING SIGNIFICANT RISE OR FALL OF BLOOD GLUCOSE MAY AFFECT ACCURACY OF SENSOR GLUCOSE READINGS. DO NOT CALIBRATE IF THE OUT OF RANGE SYMBOL SHOWS IN THE STATUS AREA. DO NOT CALIBRATE IF THE GLUCOSE READING ERROR SYMBOL SHOWS IN THE STATUS AREA."

    Description of Event or Problem · 1

    PATIENT'S FATHER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2015, TO REPORT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITORING (CGM) SYSTEM AND THE BLOOD GLUCOSE (BG) METER ON (B)(6) 2015. THE SENSOR WAS INSERTED ON (B)(6) 2015. PATIENT DID NOT CALIBRATE ACCORDING TO USER GUIDE RECOMMENDATIONS. THE PATIENT'S FATHER DID NOT REPORT INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403581 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-27 5198073

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR