BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 2553065 · Received April 25, 2012

    Report

    Report Number
    3004753838-2012-00110
    Event Type
    Other
    Date Received
    April 25, 2012
    Date of Event
    April 5, 2012
    Report Date
    April 6, 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

    PT'S MOTHER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2012, TO REPORT THAT A SENSOR WIRE FRAGMENT HAD REMAINED INSIDE PT'S SKIN AFTER SENSOR REMOVAL WHEN READINGS ABRUPTLY STOPPED. PT WAS ABLE TO PULL IT OUT OF HER SKIN. AT THE TIME OF HER CALL TO DEXCOM TECHNICAL SUPPORT, PT'S MOTHER REPORTS THAT PT HAD INITIALLY FELT SOME IRRITATION AT THE INSERTION SITE BUT WAS FEELING FINE NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR MDS DEXCOM, INC. 9500-03 5038114

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Other