BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 2925826 · Received January 22, 2013

    Report

    Report Number
    3004753838-2013-00018
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    December 23, 2012
    Report Date
    December 24, 2012
    Manufacturer
    DEXCOM INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2012 TO REPORT THAT ON (B)(6) 2012 AROUND 11:30 AM, DURING A SENSOR INSERTION, HE HIT A BLOOD VESSEL AND STARTED BLEEDING. SINCE BLEEDING WOULDN'T STOP, PATIENT'S WIFE TOOK HIM TO THE HOSPITAL WHERE HE WAS TREATED. PATIENT STATED THAT HE IS ON A CONCOMITANT USE OF BLOOD THINNERS WHICH COMPLICATES BLOOD COAGULATION. AT THE TIME OF HIS CALL TO DEXCOM TECHNICAL SUPPORT, DESPITE SOME SLIGHT BRUISING AT THE INSERTION SITE, PATIENT REPORTED THAT HE WAS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29543 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM INC. 9500-27 5045957

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization| O PLAVIX