BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 1692461 · Received May 12, 2010

    Report

    Report Number
    3004753838-2010-00090
    Event Type
    Other
    Date Received
    May 12, 2010
    Date of Event
    April 26, 2010
    Report Date
    April 26, 2010
    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

    PT CONTACTED DEXCOM TECH SUPPORT ON (B)(6) 2010 TO REPORT THAT SHE EXPERIENCED A RETAINED DISTAL SENSOR FRAGMENT. PT HAD REMOVED HER SENSOR POD IN THE NORMAL MANNER AFTER 7 DAYS OF WEAR AND "SAW SOMETHING BLACK THAT FELT LIKE A PART OF THE WIRE LEFT IN HER SKIN." PT WAS UNSUCCESSFUL IN ATTEMPTING TO REMOVE THE RETAINED DISTAL FRAGMENT, BUT DID NOT EXPERIENCE ANY DISCOMFORT FROM THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR MDS DEXCOM, INC. 9500-03 5007079

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other