BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 2278745 · Received September 23, 2011

    Report

    Report Number
    3004753838-2011-00276
    Event Type
    Other
    Date Received
    September 23, 2011
    Date of Event
    August 24, 2011
    Report Date
    August 25, 2011
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P050012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    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 CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2011 TO REPORT THAT DURING A SOCCER GAME, PATIENT FELT SOME DISCOMFORT AND RECEIVED AN ERROR MESSAGE ON HIS RECEIVER. UPON REMOVAL OF SENSOR, PATIENT CLAIMS THAT SENSOR WAS STILL IN HIS SKIN BUT THAT HE WAS UNABLE TO SEE IT. AT THE TIME OF HIS CALL TO DEXCOM TECHNICAL SUPPORT, PATIENT REPORTS FEELING FINE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other