BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 4381854 · Received January 5, 2015

    Report

    Report Number
    3004753838-2015-10020
    Event Type
    Malfunction
    Date Received
    January 5, 2015
    Date of Event
    December 8, 2014
    Report Date
    December 8, 2014
    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 SENSOR DEVICE WAS NOT RETURNED FOR EVALUATION. THE TRANSMITTER DEVICE (9500-27) THAT WAS BEING USED WITH THE SENSOR DEVICE 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 COMPLAINT OF INACCURATE BLOOD GLUCOSE VALUES COULD NOT BE CONFIRMED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 TO REPORT CONTINUOUS GLUCOSE MONITORING (CGM) INACCURACIES COMPARED TO BLOOD GLUCOSE METER ON (B)(6) 2014. AT THE TIME OF CONTACT, THE PATIENT DID NOT REPORT ANY INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2753 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-27 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR