BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3165877 · Received June 12, 2013

    Report

    Report Number
    3004753838-2013-00145
    Event Type
    Malfunction
    Date Received
    June 12, 2013
    Date of Event
    February 6, 2013
    Report Date
    May 13, 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

    PATIENT'S CALLED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2013 TO REPORT THAT ON (B)(6) 2013 SENSOR HAD BECOME DETACHED FROM SENSOR UPON SENSOR REMOVAL. SENSOR WAS FOUND ADHERED TO SENSOR POD ADHESIVE. PATIENT REPORTS NO ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265482 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM INC. 9500-27

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR