BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 2419118 · Received December 21, 2011

    Report

    Report Number
    3004753838-2011-00359
    Event Type
    Malfunction
    Date Received
    December 21, 2011
    Date of Event
    December 2, 2011
    Report Date
    December 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 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 HAD SUFFERED A HYPOGLYCEMIC EVENT DUE TO CGM'S INACCURACIES. PATIENT REPORTS TWO INACCURACIES DURING WHICH CGM/BG WERE 91/60 AND 182/400 MG/DL, THE FIRST ONE BEING THE VALUES NOTED DURING THE HYPOGLYCEMIC INCIDENT. PATIENT REQUIRED MEDICAL INTERVENTION, WAS TREATED WITH IV BUT WAS NOT HOSPITALIZED. AT THE TIME OF HER CALL TO DEXCOM TECHNICAL SUPPORT PATIENT STATES SHE WAS 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 Other