BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3222270 · Received July 12, 2013

    Report

    Report Number
    3004753838-2013-00182
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 11, 2013
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P050012
    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) 2013 TO REPORT THAT ON (B)(6) 2013, SHE HAD EXPERIENCED A HYPOGLYCEMIC EVENT. PATIENT PASSED OUT AND A FAMILY MEMBER CALLED THE FIRE DEPARTMENT. UPON ARRIVAL, THE EMERGENCY RESPONDERS ADMINISTERED IV GLUCOSE TO PATIENT.PATIENT REPORTS THAT SHE EXPERIENCED DISCREPANCIES BETWEEN HER BLOOD GLUCOSE (BG) METER AND CGM PRIOR TO THE INCIDENT. SHE DOES NOT RECALL HER BG OR CGM VALUES AT THE TIME OF INCIDENT.AT THE TIME OF HER CALL TO TECHNICAL SUPPORT, PATIENT REPORTED BEING IN FINE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324392 SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-03

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other