BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3800159 · Received May 8, 2014

    Report

    Report Number
    3004753838-2014-07906
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 11, 2014
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    PATIENT'S FATHER CONTACTED DEXCOM TECHNICAL SUPPORT VIA EMAIL ON (B)(6) 2014 TO REPORT CGM INACCURACY COMPARED TO BLOOD GLUCOSE METER ON (B)(6) 2014. THREE SUBSEQUENT ATTEMPTS TO CONTACT PATIENT WERE MADE WITH NO SUCCESS. 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
    278341 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-27

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Other