BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 2549046 · Received April 18, 2012

    Report

    Report Number
    3004753838-2012-00104
    Event Type
    Other
    Date Received
    April 18, 2012
    Date of Event
    March 29, 2012
    Report Date
    March 29, 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

    DIABETES EDUCATOR CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2012, ON BEHALF OF ONE OF THEIR TRIAL PTS, TO REPORT THAT UPON SENSOR REMOVAL, A SENSOR WIRE FRAGMENT HAD REMAINED INSERTED IN PT'S SKIN AND PT WAS ABLE TO PULL IT OUT WITHOUT ANY ISSUES. AT THE TIME OF HER CALL TO DEXCOM TECHNICAL SUPPORT ON (B)(6) 2012, DIABETES EDUCATOR REPORTED THAT PT WAS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR MDS DEXCOM, INC. 9500-03 5037902

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other