BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 2273612 · Received September 9, 2011

    Report

    Report Number
    3004753838-2011-00273
    Event Type
    Other
    Date Received
    September 9, 2011
    Date of Event
    August 21, 2011
    Report Date
    August 21, 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 SENSOR ERROR, PT'S MOTHER FOUND SENSOR STILL INSERTED IN PT'S SKIN AND WAS ABLE TO PULL IT OUT WITH HER OWN FINGERS. PT'S MOTHER REPORTS THAT PT HAD BEEN COMPLAINING OF A PAINFUL INSERTION AND WAS VERY DISTRESSED ABOUT HIS SENSOR SESSION. PT'S MOTHER FEELS THAT SENSOR MAY HAVE BEEN INSERTED TOO DEEP INTO PT'S SKIN, HENCE THE PAIN PT WAS EXPERIENCING. DURING HER CALL TO DEXCOM TECH SUPPORT PT'S MOTHER REPORTS THAT ALTHOUGH TRAUMATIZED, PT WAS FEELING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR MDS DEXCOM, INC. 9500-03 5014472

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR