BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 1842560 · Received September 14, 2010

    Report

    Report Number
    3004753838-2010-00176
    Event Type
    Other
    Date Received
    September 14, 2010
    Date of Event
    August 26, 2010
    Report Date
    August 26, 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 FATHER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2010 TO REPORT THAT PT REMOVED SENSOR WIRE AND THAT IT LOOKED A LOT SHORTER THAN USUAL. PT'S FATHER CONFIRMED THAT THE WIRE WAS SHORT AND ASSUMED THAT THE DISTAL FRAGMENT REMAINED UNDER THE PT'S SKIN. PT EXPERIENCED NO PAIN OR DISCOMFORT. AT THE TIME, THE PT'S FATHER CALLED DEXCOM TECHNICAL SUPPORT, PT WAS HEALTHY AND DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR MDS DEXCOM, INC. 9500-03 5009730-633

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Other