BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 2202255 · Received August 2, 2011

    Report

    Report Number
    3004753838-2011-00233
    Event Type
    Injury
    Date Received
    August 2, 2011
    Date of Event
    June 29, 2011
    Report Date
    July 5, 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 CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2011 TO REPORT THAT SHE HAD EXPERIENCED A SEIZURE DUE TO A HYPOGLYCEMIC EVENT. PT CLAIMS THAT CGM DID NOT ALERT HER OR HER HYPOGLYCEMIC EVENT. PT DID NOT REQUIRE MEDICAL INTERVENTION BUT PT'S HUSBAND, WHO'S A SURGEON, ADMINISTERED GLUCAGON TO GET HER BG BACK UP. PT DID NOT MEASURE HER BG DURING NOR AFTER HYPOGLYCEMIC EPISODE. AT THE TIME OF HER CALL TO DEXCOM TECHNICAL SUPPORT, PT REPORTS FEELING FINE.

    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 45 YR Other