BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 2990580 · Received March 5, 2013

    Report

    Report Number
    3004753838-2013-00053
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 5, 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 IN THE ABSENCE OF ANY EVIDENCE OF PHYSICAL HARM OR NECESSITY FOR INTERVENTION.

    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 CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2013 TO REPORT THAT UPON SENSOR POD REMOVAL, FOLLOWING A SEEMINGLY FAULTY SENSOR INSERTION, PATIENT NOTICED THAT SENSOR WIRE HAD REMAINED INSERTED IN HER SKIN. PATIENT PULLED SENSOR OUT OF HER SKIN WITH HER OWN FINGERS. PATIENT HAD NO ADDITIONAL CONCERNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92941 SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR MDS MDS DEXCOM INC. 9500-03 5046572

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other