BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 2171326 · Received July 14, 2011

    Report

    Report Number
    3004753838-2011-00208
    Event Type
    Injury
    Date Received
    July 14, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 14, 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 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 UPON REMOVAL OF TWO SENSORS, WORN FOR 1 AND 3 DAYS RESPECTIVELY, PT OBSERVED BUMPS AND BLEEDING AT THE SITE OF INSERTION. PT CONSULTED WITH A PHYSICIAN (PT'S FATHER) WHO ADVISED THAT PT APPLIES ALCOHOL AND IODINE TO INSERTION SITE PRIOR TO INSERTION. AT THE TIME OF HIS CALL TO DEXCOM TECHNICAL SUPPORT ON (B)(6) 2011, PT REPORTED THAT HE WAS DOING FINE. THIS IS MDR 2 OF 3 FOR THE COMPLAINT. SEE MDR #3004753838-2011-00209, 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 5013141

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other