BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 4800443 · Received May 27, 2015

    Report

    Report Number
    3004753838-2015-15024
    Event Type
    Malfunction
    Date Received
    May 27, 2015
    Date of Event
    April 21, 2015
    Report Date
    April 29, 2015
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION AND DATA WAS NOT PROVIDED; THEREFORE, THE REPORTED COMPLAINT OF INACCURACIES CANNOT BE CONFIRMED. IT WAS REPORTED THAT THE PATIENT DID NOT INSERT THE SENSOR IN AN APPROVED SITE ACCORDING TO THE USER'S GUIDE. IT SHOULD BE NOTED THAT THE DEXCOM G4® PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM STATES: SENSOR PLACEMENT AND INSERTION IS NOT APPROVED FOR SITES OTHER THAN THE BELLY (ABDOMEN).

    Description of Event or Problem · 1

    FOREIGN DISTRIBUTOR CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2015, 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. PATIENT INSERTED THE SENSOR ON ARM. FOREIGN DISTRIBUTOR DID NOT REPORT INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342662 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-35 5194468

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR