BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3830322 · Received May 23, 2014

    Report

    Report Number
    3004753838-2014-05618
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    April 25, 2014
    Report Date
    April 28, 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 HUSBAND CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 AND CLAIMED THAT ON (B)(6) 2014, UPON SENSOR APPLICATOR REMOVAL, SENSOR WIRE REMAINED IN APPLICATOR. NO MEDICAL INTERVENTION WAS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307467 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS, PRODUCT CODE: MDS MDS DEXCOM, INC. 9500-27 5132242

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other