BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 4914146 · Received July 14, 2015

    Report

    Report Number
    3004753838-2015-16988
    Event Type
    Malfunction
    Date Received
    July 14, 2015
    Date of Event
    June 6, 2015
    Report Date
    June 18, 2015
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    FOREIGN DISTRIBUTOR CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2015,ON PATIENT'S BEHALF TO REPORT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITORING (CGM) SYSTEM AND THE BLOOD GLUCOSE (BG) METER ON (B)(6) 2015. THE SENSOR WAS INSERTED ON (B)(6) 2015. FOREIGN DISTRIBUTOR DID NOT REPORT INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455782 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-35 5199121

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR