BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 5141313 · Received October 9, 2015

    Report

    Report Number
    3004753838-2015-65975
    Event Type
    Malfunction
    Date Received
    October 9, 2015
    Date of Event
    September 12, 2015
    Report Date
    September 12, 2015
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000019
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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. ADDITIONALLY, AN EXPIRED SENSOR WAS USED. THE DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM USER'S GUIDE STATES: DO NOT INSERT SENSORS PAST THE EXPIRATION DATE. THE EXPIRATION DATE FORMAT IS YYYY-MM-DD. INSERT SENSORS ON OR BEFORE THE END OF THE CALENDAR DAY PRINTED ON THE SENSOR PACKAGE LABEL.

    Description of Event or Problem · 1

    PATIENT'S HUSBAND CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2015 TO REPORT CONTINUOUS GLUCOSE MONITORING (CGM) INACCURACIES COMPARED TO BLOOD GLUCOSE (BG) METER THAT OCCURRED ON (B)(6) 2015. THE SENSOR WAS INSERTED ON (B)(6) 2015. PATIENT USED AN EXPIRED SENSOR. CALIBRATION WAS NOT PERFORMED CORRECTLY. AT THE TIME OF CONTACT, NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671233 DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-27 5191511 00386270000019

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR