BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 2500912 · Received March 16, 2012

    Report

    Report Number
    3004753838-2012-00062
    Event Type
    Other
    Date Received
    March 16, 2012
    Date of Event
    February 18, 2012
    Report Date
    February 20, 2012
    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

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2012 TO REPORT THAT UPON SENSOR REMOVAL DUE TO A SENSOR ERROR, PATIENT THINKS THAT SENSOR WIRE WAS STILL UNDERNEATH HER SKIN. PATIENT ALSO REPORTS THAT THE SKIN AT THE INSERTION SITE IS RED AND TENDER. AT THE TIME OF HER CALL TO DEXCOM TECHNICAL SUPPORT, PATIENT HAD SCHEDULED AN APPOINTMENT WITH HER DERMATOLOGIST BUT 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

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other