BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 2970360 · Received February 20, 2013

    Report

    Report Number
    3004753838-2013-00045
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 22, 2013
    Manufacturer
    DEXCOM INC.
    Product Code
    MDS
    PMA / PMN Number
    P050012
    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 INTHE ABSENCE OF ANY EVIDENCE OF PHYSICAL HARM OR NECESSITY FOR INTERVENTION.

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2013 TO REPORT THAT UPON SENSOR POD REMOVAL, PATIENT HAD TO PULL SENSOR OUT WITH TWEEZERS.THE INFORMATION THAT WAS PROVIDED TO DEXCOM BY PATIENT IS INCOMPLETE. DEXCOM HAS ATTEMPTED TO CONTACT PATIENT SEVERAL TIMES IN ORDER TO COLLECT MORE INFORMATION AROUND THE TIME OF THE EVENT BUT HAS NOT BEEN ABLE TO REACH PATIENT.THIS IS MDR 1 OF 2 FOR THE COMPLAINT. SEE MDR # 3004753838-2013-00046 FOR REPORT 2 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73255 SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR MDS MDS DEXCOM INC. 9500-03

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other