BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 2231617 · Received August 16, 2011

    Report

    Report Number
    3004753838-2011-00249
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 25, 2011
    Report Date
    July 25, 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 THAT SHE WAS RECENTLY HOSPITALIZED DUE TO A HYPERGLYCEMIC EVENT DURING WHICH PATIENT CLAIMS THAT HER BG WAS IN THE APPROXIMATELY 600 MG/DL WHILE HER CGM LEVELS WERE NORMAL (PATIENT DOES NOT OFFER VALUE). PATIENT OFFERED ONE INACCURACY INSTANCE AS AN EXAMPLE WHERE BG/CGM WAS 153/315 MG/DL. DURING HER CALL TO DEXCOM TECHNICAL SUPPORT, PATIENT WAS OUT OF THE HOSPITAL. DEXCOM TECHNICAL SUPPORT HAS ATTEMPTED SEVERAL TIMES TO REACH PATIENT IN ORDER TO COLLECT MORE INFORMATION BUT WAS UNSUCCESSFUL IN DOING SO.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization| O