BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 2101438 · Received May 2, 2011

    Report

    Report Number
    3004753838-2011-00118
    Event Type
    Injury
    Date Received
    May 2, 2011
    Date of Event
    April 3, 2011
    Report Date
    April 6, 2011
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P050012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    PT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2011 TO REPORT THAT SHE EXPERIENCED AN ALLERGIC REACTION TO THE SENSOR ADHESIVE PATCH ON TWO OCCASIONS. PT'S SKIN IS RED AND SCALY BUT SHOWS NO SIGN OF INFECTION. PT IS APPLYING HYDROCORTISONE CREAM ON THE AFFECTED AREA PER HER DOCTOR'S RECOMMENDATION. DURING A F/U CALL BY DEXCOM TECHNICAL SUPPORT ON (B)(6) 2011, THE PT REPORTED EXPERIENCING ITCHING FOR 10 DAYS, LEAVING A PINKISH, ROUGH PATCH. THERE WAS NO INFECTION OR BRUISING OF THE AFFECTED AREA. PT STATED THAT SHE DID NOT RECEIVE A RASH OR ALLERGIC REACTION TO PREVIOUS SENSORS. PT SHOWED THE AFFECTED AREA TO HER PHYSICIAN, WHO ADVISED HER TO APPLY NEOSPORIN OINTMENT. THE PT'S CONDITION WAS NORMAL AT THE TIME OF THIS CALL. THIS IS MDR 2 OF 2 FOR THE COMPLAINT. SEE MDR 3004753838-2011-00117 FOR REPORT 1 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR MDS DEXCOM, INC. 9500-03 5014457

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other