BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 4897177 · Received July 7, 2015

    Report

    Report Number
    3004753838-2015-05553
    Event Type
    Malfunction
    Date Received
    July 7, 2015
    Date of Event
    June 10, 2015
    Report Date
    June 10, 2015
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    HOLD DJR 07/08. PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2015 TO REPORT THAT ON (B)(6) 2015, PATIENT EXPERIENCED AN INTERMITTENT OUT OF RANGE SIGNAL. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438757 DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9438-01 5126246

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR