BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 2090803 · Received May 9, 2011

    Report

    Report Number
    3004753838-2011-00134
    Event Type
    Injury
    Date Received
    May 9, 2011
    Date of Event
    April 2, 2007
    Report Date
    April 11, 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

    DEXCOM CONFIRMED THAT THIS LOT OF PRODUCT WAS PROPERLY STERILIZED PRIOR TO SHIPMENT. CURRENTLY, IT IS UNKNOWN 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

    PATIENT'S MOTHER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2011 TO REPORT THAT PATIENT EXPERIENCED AN INFECTION AND RASH FROM THE SENSOR ADHESIVE PATCH ON THE LAST TWO SENSORS. PATIENT'S PHYSICIAN EXAMINED THE RASH AND RECOMMENDED AN ANTIBIOTIC CREAM. THIS IS MDR 1 OF 2 FOR THE COMPLAINT. SEE MDR #3004753838-2011-00135 FOR REPORT 2 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR MDS DEXCOM, INC. 9500-03 5012892

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Other