BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 1912858 · Received November 9, 2010

    Report

    Report Number
    3004753838-2010-00195
    Event Type
    Other
    Date Received
    November 9, 2010
    Date of Event
    October 19, 2010
    Report Date
    October 20, 2010
    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.

    Description of Event or Problem · 1

    PT'S MOTHER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2010 TO REPORT THAT PT EXPERIENCED A FAILED SENSOR FIVE DAYS AFTER INSERTION. PT'S MOTHER REPORTED THAT, UPON REMOVING THE SENSOR, SHE FOUND PART OF THE WIRE HALF UNDERNEATH PT'S SKIN AND HALF ABOVE HIS SKIN. PT'S MOTHER REMOVED THE RETAINED SENSOR WIRE FRAGMENT AND REPORTED THERE WAS A SMALL BUMP AT THE INSERTION SITE. NO MEDICAL INTERVENTION WAS REQUIRED AND PT WAS FINE AND HEALTHY AT THE TIME OF HIS MOTHER'S CALL TO DEXCOM TECHNICAL SUPPORT. THIS IS MDR 2 OF 2 FOR THE COMPLAINT (REFER TO MDR #3004753838-2010-00187 FOR MDR 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 5009719

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Other