BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 4901659 · Received July 9, 2015

    Report

    Report Number
    3004753838-2015-16783
    Event Type
    Malfunction
    Date Received
    July 9, 2015
    Date of Event
    June 14, 2015
    Report Date
    June 14, 2015
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SUBSEQUENT TO THE INITIAL MDR, THE COMPLAINT SENSOR WAS NOT RETURNED TO DEXCOM. THE PEDIATRIC RECEIVER (PART NUMBER STK-KD-PNK/SERIAL NUMBER (B)(4)/LOT NUMBER 5191136), BEING USED WITH THE COMPLAINT SENSOR, WAS RETURNED ON 07/31/2015. THE RETURNED RECEIVER WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. FUNCTIONAL TESTING WAS PERFORMED AND THE REPORTED FAULT COULD NOT BE REPRODUCED AND THERE WAS NO FAILURE DETECTED. THE DEVICE WAS DETERMINED TO BE OPERATING WITHIN THE REQUIRED SPECIFICATIONS WITHOUT MALFUNCTION; HOWEVER A REVIEW OF THE DIAGNOSTIC CHART CONFIRMED THE REPORTED EVENT OF INACCURACIES. A ROOT CAUSE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION; HOWEVER, THE DATA LOG WAS PROVIDED BY THE PATIENT. IT WAS DOWNLOADED AND REVIEWED ON 07/01/2015 CONFIRMING THE REPORTED EVENT OF INACCURATE READINGS.

    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 REPORT INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446777 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-27 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR