BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 2062623 · Received April 8, 2011

    Report

    Report Number
    3004753838-2011-00092
    Event Type
    Injury
    Date Received
    April 8, 2011
    Date of Event
    March 19, 2011
    Report Date
    March 21, 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 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 CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2011 TO REPORT THAT HE WAS EXCESSIVELY BLEEDING AT HIS SENSOR INSERTION SITE. PATIENT'S WIFE REMOVED THE SENSOR AND TOOK THE PATIENT TO THE EMERGENCY ROOM, WHERE THEY APPLIED A HEAVY-PRESSURE BANDAGE TO STOP THE BLEEDING. PATIENT'S BLEEDING HAD NOT STOPPED BY THE NEXT DAY, SO HE RETURNED TO THE EMERGENCY ROOM, WHERE HE GOT TWO STITCHES TO STOP THE BLEEDING. PATIENT REPORTED THAT HE CURRENTLY TAKES A BLOOD THINNER MEDICATION. PATIENT WAS FINE AT THE TIME OF HIS CALL TO DEXCOM TECHNICAL SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR MDS DEXCOM, INC. 9500-03 5014140

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| O