BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 4367485 · Received December 29, 2014

    Report

    Report Number
    3004753838-2014-37018
    Event Type
    Malfunction
    Date Received
    December 29, 2014
    Date of Event
    December 3, 2014
    Report Date
    December 3, 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).

    Additional Manufacturer Narrative · 1

    (B)(4). SUBSEQUENT TO THE INITIAL MDR, THE COMPLAINT SENSOR DEVICE WAS NOT RETURNED TO DEXCOM. THE TRANSMITTER DEVICE (9438-05), USED WITH THE COMPLAINT SENSOR DEVICE, WAS RETURNED ON (B)(4) 2014. THE RETURNED 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 REPORTED EVENT OF INACCURACIES COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    PATIENT'S FATHER 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'S FATHER DID NOT REPORT ANY INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853145 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-27 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR