BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 2152879 · Received June 28, 2011

    Report

    Report Number
    3004753838-2011-00196
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    May 31, 2011
    Report Date
    May 31, 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 UNK 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

    PT'S FATHER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2011 TO REPORT INACCURATE CGM READINGS. PT HAD BECOME UNCONSCIOUS ON THREE DIFFERENT OCCASIONS DUE TO HYPOGLYCEMIC EPISODES AND PT'S FATHER HAD TO TREAT PT WITH GLUCAGON. PT'S FATHER REPORTS THAT CGM WAS NOT ALERTING PT OF EXTREME LOWS. DURING ONE OF THESE EPISODES, BG WAS MEASURED AT 21 MG/DL WHILE THE RECEIVER WAS READING IN THE 100'S MG/DL. DURING OTHER EPISODES, PT'S FATHER REPORTED THAT CGM WAS READING 111 MG/DL, 149 MG/DL AND 200 MG/DL WHEN PT WAS EXPERIENCING A HYPOGLYCEMIC EPISODE (BG UNKNOWN). PT WAS DOING FINE AT THE TIME OF HER FATHER'S CALL TO DEXCOM TECHNICAL SUPPORT. THIS IS MDR 1 OF 3 FOR THE COMPLAINT. SEE MDRS #3004753838-2011-00197 AND 00198 FOR REPORTS 2 AND 3 OF 3, RESPECTIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR MDS DEXCOM, INC. 9500-03 5015595

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other