BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 2160795 · Received July 5, 2011

    Report

    Report Number
    3004753838-2011-00206
    Event Type
    Malfunction
    Date Received
    July 5, 2011
    Date of Event
    June 5, 2011
    Report Date
    June 9, 2011
    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 CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2011 TO REPORT AN INACCURACY IN CGM READINGS DURING AN EXTREME LOW. CGM WAS READING 109 MG/DL, WHILE BG WAS MEASURED AT 41 MG/DL. PATIENT CALLED THE PARAMEDICS AND WAS ADMINISTERED GLUCAGON ALTHOUGH SHE DID NOT BECOME UNCONSCIOUS DURING HYPOGLYCEMIC EPISODE. PATIENT'S DATA SHOWED HOWEVER THAT THE SENSOR HAD NOT BEEN CALIBRATED IN MORE THAN 12 HOURS. PATIENT WAS FINE AT THE TIME OF HER CALL TO DEXCOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR MDS DEXCOM, INC. 9500-03 5015615

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other