BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3821570 · Received May 20, 2014

    Report

    Report Number
    3004753838-2014-08226
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    March 23, 2014
    Report Date
    March 25, 2014
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P050012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A PATIENT ON A 7-DAY TRIAL CONTACTED DEXCOM TECHNICAL SUPPORT (B)(6) 2014 TO REPORT CGM INACCURACY COMPARED TO BLOOD GLUCOSE METER ON (B)(6) 2014. AT THE TIME OF THE CALL TO DEXCOM TECHNICAL SUPPORT, PATIENT DID NOT REPORT ANY MEDICAL INTERVENTION OR INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300376 SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-03 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other