BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3854756 · Received June 6, 2014

    Report

    Report Number
    3004753838-2014-05654
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 11, 2014
    Report Date
    May 11, 2014
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 AND CLAIMED THAT ON (B)(6) 2014, UPON SENSOR POD REMOVAL, SENSOR WIRE REMAINED LEFT BEHIND IN PATIENT. AGAINST USER GUIDE RECOMMENDATIONS, TRANSMITTER HAD BEEN REMOVED PRIOR TO SENSOR POD REMOVAL. AT THE TIME OF THE CALL WITH DEXCOM TECHNICAL SUPPORT, PATIENT REPORTED INSERTION SITE WAS STINGING. PATIENT REPORTED NO ADDITIONAL DISCOMFORT. NO MEDICAL INTERVENTION WAS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331589 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS, PRODUCT CODE: MDS MDS DEXCOM, INC. 9500-27 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other