BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 4673374 · Received April 9, 2015

    Report

    Report Number
    3004753838-2015-13104
    Event Type
    Malfunction
    Date Received
    April 9, 2015
    Date of Event
    March 5, 2015
    Report Date
    March 15, 2015
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, THE DATA LOG WAS PROVIDED BY THE PATIENT. THE DATA WAS REVIEWED ON (B)(6) 2015 AND CONFIRMED THE REPORTED EVENT OF INACCURATE READINGS.

    Additional Manufacturer Narrative · 1

    (B)(4). DESCRIBE EVENT OR PROBLEM - ADDITIONAL.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MDR, THE COMPLAINT SENSOR WAS NOT RETURNED TO DEXCOM. THE RECEIVER (PART NUMBER STK-GL-PNK/SERIAL NUMBER (B)(4) LOT NUMBER 5191806), BEING USED WITH THE COMPLAINT SENSOR, WAS RETURNED ON 12/29/2015. 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.

    Description of Event or Problem · 1

    THE TRANSMITTER (PART NUMBER STT-GL-003 /SERIAL NUMBER (B)(4)/LOT NUMBER 5193034) BEING USED WITH THE SENSOR AND RECEIVER WAS RETURNED FOR EVALUATION. THE DEVICE 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 REPORTED EVENT OF INACCURACIES WAS NOT CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

    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. NO INJURIES OR MEDICAL INTERVENTION WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236303 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-27 5193931

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR