BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 1923553 · Received December 6, 2010

    Report

    Report Number
    3004753838-2010-00211
    Event Type
    Injury
    Date Received
    December 6, 2010
    Date of Event
    November 17, 2010
    Report Date
    November 19, 2010
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P050012
    Adverse Event
    Yes
    Product Problem
    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'S MOTHER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2010 TO REPORT THAT HER DAUGHTER EXPERIENCED AN INACCURACY IN CGM READINGS DURING AN EXTREME LOW. PATIENT WAS COHERENT BUT WAS HAVING TROUBLE STANDING SO PARAMEDICS WERE CALLED. PATIENT'S BLOOD GLUCOSE WAS IN THE 20 MG/DL RANGE WHEN PARAMEDICS ARRIVED. PARAMEDICS ADMINISTERED GLUCOSE, AND PATIENT RECOVERED. PATIENT'S MOTHER REPORTED THAT PATIENT'S CGM/FINGERSTICK VALUES WERE: 77/20, 84/45, 171/113, 91/108, AND 168/108 MG/DL. PATIENT WAS FINE AT THE TIME OF THE MOTHER'S 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 5009866

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other