BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3411925 · Received October 15, 2013

    Report

    Report Number
    3004753838-2013-00301
    Event Type
    Malfunction
    Date Received
    October 15, 2013
    Date of Event
    September 16, 2013
    Report Date
    September 16, 2013
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEXCOM, INC. AND FDA AGREED DURING A FACILITY INSPECTION THAT ANY POSSIBLE BROKEN SENSOR WIRE WAS A REPORTABLE EVENT, EVEN IN THE ABSENCE OF ANY EVIDENCE OF PHYSICAL HARM OR NECESSITY FOR INTERVENTION.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2013 AND REPORTED THAT ON (B)(6) 2013, THE SENSOR WAS REMOVED AND THE SENSOR WIRE REMAINED IN THE PATIENT'S BODY. NO MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528115 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-27 5076402

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other