BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3841465 · Received May 30, 2014

    Report

    Report Number
    3004753838-2014-08344
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    April 30, 2014
    Report Date
    May 2, 2014
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE TRANSMITTER WAS RETURNED TO THE DISTRIBUTOR FOR EVALUATION. THE DISTRIBUTOR EVALUATION RESULTS WERE RECEIVED ON (B)(6) 2014. ANALYSIS OF THE DATA LOG FROM (B)(6) 2014 IDENTIFIED ONE DISCREPANCY BETWEEN THE CGM READINGS AND THE CAPILLARY BLOOD GLUCOSE READINGS; THIS SINGLE DISCREPANCY INDICATES THE NEED FOR CGM CALIBRATION AND DOES NOT INDICATE OVERWRITTEN/INCORRECT SOURCE OR TRANSMISSION DATA. THIS DISCREPANCY OCCURRED ON (B)(6) BETWEEN 9:30AM AND 10:45AM. THE CGM READINGS WERE 340MG/DL AND THE CAPILLARY READING WAS 235MG/DL. A CGM CALIBRATION WAS PERFORMED AT 10:45 AM. AFTER THE CALIBRATION THE CGM READINGS WERE THEN IN AGREEMENT WITH THE CAPILLARY READINGS. THE TRANSMITTER 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. THE COMPLAINT OF CGM INACCURACY COMPARED TO BLOOD GLUCOSE METER WAS CONFIRMED BASED ON THE DATA LOG REVIEW.

    Description of Event or Problem · 1

    AN INTERNATIONAL DISTRIBUTOR CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 TO REPORT CGM INACCURACY COMPARED TO BLOOD GLUCOSE METER ON (B)(6) 2014. THE DISTRIBUTOR CLAIMS A CLASSMATE OF THE PATIENT WAS USING A "ROGER INSPIRO" HEARING AID DEVICE AND A "PHONAK" AMPLIFIER THAT INTERFERED WITH THE CGM SYSTEM RESULTING IN INACCURATE READINGS. THE DISTRIBUTOR ALSO REPORTED THE DEXCOM CGM SYSTEM REPORTED ACCURATE VALUES COMPARED TO BLOOD GLUCOSE METER READINGS ON DAYS WHEN THE CHILDREN WERE SEPARATED OR THE HEARING AID DEVICE WAS SWITCHED OFF. THERE WAS NO REPORT OF ANY INJURY OR MEDICAL INTERVENTION AT THE TIME OF CONTACT WITH DEXCOM TECHNICAL SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318291 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9438-01 5121242

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Other