BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 2379438 · Received November 18, 2011

    Report

    Report Number
    3004753838-2011-00306
    Event Type
    Other
    Date Received
    November 18, 2011
    Date of Event
    September 27, 2011
    Report Date
    September 27, 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 TECHNICAL SUPPORT ON (B)(6) 2011 TO REPORT THAT UPON SENSOR REMOVAL DUE TO SENSOR ERROR SHE NOTICED THAT SENSOR WIRE WAS SHORTER THAN USUAL BUT NOTES THAT NO WIRE WAS VISIBLE UNDER THE SKIN. DURING HER CALL TO DEXCOM TECHNICAL SUPPORT PT'S MOTHER REPORTS THAT 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 5015542

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Other