BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 2652015 · Received June 29, 2012

    Report

    Report Number
    3004753838-2012-00190
    Event Type
    Other
    Date Received
    June 29, 2012
    Date of Event
    May 24, 2012
    Report Date
    June 19, 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 CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2012 TO REPORT THAT UPON SENSOR REMOVAL, PT BELIEVED THAT A PORTION OF THE SENSOR WIRE REMAINED UNDER HIS SKIN. PT REPORTS A SMALL RED SPOT AT THE INSERTION SITE AT THE TIME OF EVENT. AT THAT TIME OF HIS CALL TO DEXCOM TECHNICAL SUPPORT, PT REPORTS REDNESS AT THE INSERTION SITE HAD SUBSIDED.

    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 39 YR Other