BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 2092912 · Received May 9, 2011

    Report

    Report Number
    3004753838-2011-00137
    Event Type
    Other
    Date Received
    May 9, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 14, 2011
    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 FATHER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2011 TO REPORT THAT PT EXPERIENCED A POSSIBLE BROKEN SENSOR WIRE. UPON REMOVAL, THE SENSOR APPEARED TO BE HALF ITS USUAL LENGTH. PT'S FATHER WAS UNABLE TO VISIBLY CONFIRM THAT THE BROKEN WIRE WAS UNDER THE SKIN BUT STATED THAT HE WAS NOT REALLY WORRIED ABOUT THE SENSOR WIRE. NO MEDICAL INTERVENTION WAS REQUIRED, AND PT WAS NOT EXPERIENCING ANY DISCOMFORT OR SYMPTOMS OF INFECTION AT THE TIME OF HER FATHER'S CALL TO DEXCOM TECHNICAL SUPPORT. DURING A F/U CALL BY DEXCOM TECHNICAL SUPPORT ON (B)(6) 2011, PT'S FATHER REPORTED THAT THE PT HAD NOT EXPERIENCED ANY WIRE REMOVE ITSELF FROM THE SKIN BUT HAD NO PROBLEMS SINCE THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR MDS DEXCOM, INC. 9500-03 5014146

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Other