BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 2062676 · Received April 11, 2011

    Report

    Report Number
    3004753838-2011-00100
    Event Type
    Injury
    Date Received
    April 11, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 24, 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 A REACTION TO THE NEEDLE INSERTION SITE. PT IS PREGNANT AND REPORTED THAT, UPON REMOVING HER SENSORS, SHE HAD RED, ITCHY, RAISED BUMPS THE SIZE OF QUARTERS AT THE NEEDLE INSERTION SITE. PT REPORTS A LOT OF DISCOMFORT DUE TO ITCHINESS BUT REPORTED THAT SHE HAD NO INFECTION OR DISCHARGE AT THE INSERTION SITES. SHE REPORTED THAT SOME OF THE SITES ARE STILL ITCHY AND RED BUT THAT THEY SEEM TO BE GOING DOWN A LITTLE. PT CONSULTED HER NURSE PRACTITIONER, WHO DID NOT PRESCRIBE MEDICATION BECAUSE PT IS PREGNANT. PT WAS FINE AND HEALTHY AT THE TIME OF HER CALL TO DEXCOM TECHNICAL SUPPORT BUT REPORTED THAT SHE CONTINUES TO EXPERIENCE ITCHINESS AT THE NEEDLE INSERTION SITE.

    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 38 YR Other