BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 4962535 · Received August 3, 2015

    Report

    Report Number
    3004753838-2015-60229
    Event Type
    Malfunction
    Date Received
    August 3, 2015
    Date of Event
    July 10, 2015
    Report Date
    July 13, 2015
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SUBSEQUENT TO THE INITIAL MDR, THE COMPLAINT TRANSMITTER WAS NOT RETURNED TO DEXCOM. THE RECEIVER (PART NUMBER STK-PR-BLU/SERIAL NUMBER (B)(4)/LOT NUMBER 5200656), BEING USED WITH THE COMPLAINT TRANSMITTER, WAS RETURNED ON (B)(4) 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 AN INTERMITTENT OUT OF RANGE SIGNAL. A ROOT CAUSE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PATIENT'S MOTHER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2015 TO REPORT AN INTERMITTENT OUT OF RANGE SIGNAL ON (B)(6) 2015. AT THE TIME OF CONTACT THE PATIENT'S MOTHER DID NOT REPORT ANY INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503236 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9438-05 5201911

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR