BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 4954156 · Received July 30, 2015

    Report

    Report Number
    3004753838-2015-75021
    Event Type
    Malfunction
    Date Received
    July 30, 2015
    Date of Event
    July 15, 2015
    Report Date
    July 16, 2015
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 AFTER EXPERIENCING INACCURACY. IT SHOULD BE NOTED THAT THE DEXCOM G4® PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM USER'S GUIDE STATES: IF THE DIFFERENCE BETWEEN YOUR SENSOR GLUCOSE READING AND BLOOD GLUCOSE VALUE IS GREATER THAN 20% OF THE BLOOD GLUCOSE VALUE FOR SENSOR GLUCOSE READINGS > 80 MG/DL OR GREATER THAN 20 POINTS FOR SENSOR GLUCOSE READINGS < 80 MG/DL, WASH YOUR HANDS AND TAKE ANOTHER BLOOD GLUCOSE MEASUREMENT. IF THE DIFFERENCE BETWEEN THIS SECOND BLOOD GLUCOSE MEASUREMENT AND THE SENSOR IS STILL GREATER THAN 20% FOR SENSOR GLUCOSE READINGS > 80 MG/DL OR GREATER THAN 20 POINTS FOR SENSOR GLUCOSE READINGS < 80 MG/DL, RECALIBRATE YOUR SENSOR USING THE SECOND BLOOD GLUCOSE VALUE. THE SENSOR GLUCOSE READING WILL CORRECT OVER THE NEXT 15 MINUTES.

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497862 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-27 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR