BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 1952949 · Received January 4, 2011

    Report

    Report Number
    3004753838-2011-00002
    Event Type
    Other
    Date Received
    January 4, 2011
    Date of Event
    December 7, 2010
    Report Date
    December 7, 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'S MOTHER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2010 TO REPORT THAT HER SON EXPERIENCED A TOTAL OF FOUR FAILED SENSORS, THE FIRST OF WHICH SHE INITIALLY REPORTED IN A PREVIOUS CALL TO DEXCOM TECHNICAL SUPPORT. FOR THE THREE ADDITIONAL FAILED SENSORS REPORTED ON (B)(6) 2010, PT'S MOTHER INDICATED THAT EACH FAILED APPROX THREE DAYS AFTER INSERTION. PT'S MOTHER REPORTED THAT, UPON REMOVING THE SENSORS, SHE NOTICED THE WIRES WERE SHORTER THAN NORMAL BUT REPORTED THAT THERE WERE NO VISIBLE SENSOR WIRES PROTRUDING FROM THE PT'S SKIN. NO MEDICAL INTERVENTION WAS REQUIRED, AND PT'S MOTHER BELIEVE THAT PT EXPERIENCED NO DISCOMFORT AT THE INSERTION SITE. THIS IS MDR 2 OF 3 FOR THE COMPLAINT. SEE MDR #3004753838-2011-00001 AND #3004753838-2011-00003 FOR REPORTS 1 AND 3 OF 3, RESPECTIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR MDS DEXCOM, INC. 9500-03 5009898

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Other