BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 4969981 · Received August 5, 2015

    Report

    Report Number
    3004753838-2015-60255
    Event Type
    Malfunction
    Date Received
    August 5, 2015
    Date of Event
    July 15, 2015
    Report Date
    July 15, 2015
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE WASN'T RETURNED, BUT THE RECEIVER THAT WAS USED WITH THE DEVICE HAS BEEN RECEIVED FOR EVALUATION ON (B)(6) 2015. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). SUBSEQUENT TO THE INITIAL MDR, THE RETURNED SHARE RECEIVER (PART NUMBER STR-DR-001/SERIAL NUMBER (B)(4)/LOT NUMBER 5200908), 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.

    Description of Event or Problem · 1

    PATIENT 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 DID NOT REPORT ANY INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512344 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9438-05 5201333

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR