BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 2273576 · Received September 9, 2011

    Report

    Report Number
    3004753838-2011-00270
    Event Type
    Other
    Date Received
    September 9, 2011
    Date of Event
    August 15, 2011
    Report Date
    August 15, 2011
    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 TECH SUPPORT ON (B)(6) 2011 TO REPORT THAT, UPON REMOVAL OF SENSOR DUE TO EARLY SENSOR SHUTOFF, SHE WAS ABLE TO FEEL SOMETHING AT THE INSERTION SITE AND WAS CONCERNED THAT IT COULD BE THE REMNANT OF A BROKEN SENSOR. DURING A F/U CALL MADE BY DEXCOM TECH SUPPORT ON (B)(6) 2011, PT'S MOTHER REPORTS THAT ORIGINALLY THE NEEDLE INSERTION SITE SHOWED A LITTLE PUS BUT THAT IT HAS HEALED SINCE. THE PT WAS DOING FINE AND THE ISSUE DID NOT REQUIRE MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR MDS DEXCOM, INC. 9500-03 5015640

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Other