BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 5153586 · Received October 15, 2015

    Report

    Report Number
    3004753838-2015-90423
    Event Type
    Malfunction
    Date Received
    October 15, 2015
    Date of Event
    September 19, 2015
    Report Date
    September 19, 2015
    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). IT WAS REPORTED THAT CALIBRATION WAS NOT PERFORMED CORRECTLY. THE DEXCOM G4® PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM USER'S GUIDE STATES: DO NOT CALIBRATE WHEN YOUR RECEIVER SCREEN IS SHOWING THE RISING SINGLE ARROW OR DOUBLE ARROW. ALSO, DO NOT CALIBRATE WHEN YOUR RECEIVER SCREEN IS SHOWING THE FALLING SINGLE ARROW OR DOUBLE ARROW. CALIBRATING DURING SIGNIFICANT RISE OR FALL OF BLOOD GLUCOSE MAY AFFECT ACCURACY OF SENSOR GLUCOSE READINGS. DO NOT CALIBRATE IF THE GLUCOSE READING ERROR SYMBOL SHOWS IN THE STATUS AREA. DO NOT CALIBRATE IF THE OUT OF RANGE SYMBOL SHOWS IN THE STATUS AREA.

    Description of Event or Problem · 1

    PATIENT 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 PATIENTS SENSOR WAS INSERTED ON (B)(6) 2015. THE PATIENT DID NOT CALIBRATE ACCORDING TO USER GUIDE SPECIFICATIONS. THE PATIENT DID NOT REPORT INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684450 DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-27 5199105 00386270000019

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR