BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 2090826 · Received May 9, 2011

    Report

    Report Number
    3004753838-2011-00136
    Event Type
    Injury
    Date Received
    May 9, 2011
    Date of Event
    April 7, 2011
    Report Date
    April 13, 2011
    Manufacturer
    DEXCOM, INC.,
    Product Code
    MDS
    PMA / PMN Number
    P050012
    Adverse Event
    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 EXPERIENCED A HYPOGLYCEMIC EVENT THAT REQUIRED MEDICAL INTERVENTION. PT WAS ON HER WAY TO THE GROCERY STORE AND HAD REMOVED HER INSULIN PUMP. HER LAST RECOLLECTION WAS THAT THE DEXCOM DEVICE WAS READING 89 MG/DL. ACCORDING TO THE PARAMEDICS, A POLICE OFFICER HAD STOPPED TO CHECK ON THE PT BECAUSE SHE WAS NON-RESPONSIVE AT A STOP LIGHT. THE POLICE OFFICER ATTEMPTED TO QUESTION THE PT, FOUND HER INCOHERENT, AND CALLED THE PARAMEDICS. PT'S BLOOD GLUCOSE TAKEN BY THE PARAMEDICS AT THE SCENE WAS 20 MG/DL. PT WAS TRANSPORTED TO THE EMERGENCY ROOM, WHERE SHE WAS GIVEN SODA AND PEANUT BUTTER, AND THEN SENT HOME. PT CONTINUED TO WEAR THE SENSOR, WHICH WORKED FINE. PT REPORTED SHE WAS FINE AT THE TIME OF HER CALL TO DEXCOM TECHNICAL SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR MDS DEXCOM, INC., 9500-03 5014363

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other