BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 1964098 · Received January 10, 2011

    Report

    Report Number
    3004753838-2011-00012
    Event Type
    Other
    Date Received
    January 10, 2011
    Date of Event
    September 1, 2010
    Report Date
    November 9, 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. THE EXACT AGE OF THIS PT IS NOT REASONABLY KNOWN TO DEXCOM. THE PT'S AGE HAS BEEN ESTIMATED TO BE (B)(6) BASED ON NARRATIVE INFO CONTAINED IN THE PT'S COMPLAINT FILE. THE PT'S AGE IS REPORTED AS AN ESTIMATE PER THE INSTRUCTIONS FOR FORM FDA 3500A.

    Description of Event or Problem · 1

    PT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2010 TO REPORT THAT, ON TWO SEPARATE OCCASIONS, HE EXPERIENCED A FAILED SENSOR. ON BOTH OCCASIONS, UPON REMOVING THE SENSOR ON THE 7TH DAY OF WEAR, PT NOTICED THAT THE SENSOR WIRE WAS STICKING OUT OF HIS SKIN. PT USED TWEEZERS TO REMOVE THE WIRE FROM HIS SKIN. PT REPORTED THAT, IN BOTH INSTANCES, HE REMOVED THE TRANSMITTER BEFORE REMOVING THE SENSOR. PT REPORTED NO INFECTION AT THE INSERTION SITE. NO MEDICAL INTERVENTION WAS REQUIRED, AND PT WAS FINE AT THE TIME OF HIS CALL TO DEXCOM TECHNICAL SUPPORT. THIS IS MDR 2 OF 2 FOR THE COMPLAINT. SEE MDR # 3004753838-2011-00011 FOR REPORT 1 OF 2.

    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 Other