BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 2202296 · Received August 2, 2011

    Report

    Report Number
    3004753838-2011-00232
    Event Type
    Injury
    Date Received
    August 2, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 11, 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 HAD EXPERIENCED A HYPOGLYCEMIC EVENT. BEFORE GOING TO BED, PT FELT LOW AND INGESTED SOME ORANGE JUICE WITHOUT CHECKING HER BG. PT'S HUSBAND WAS AWAKEN BY CGM'S "LOW" ALERT AND DISCOVERED SEIZING PT IN BED. THE PARAMEDICS WERE CALLED AND THEY ADMINISTERED GLUCAGON TO PT WHOSE BG WAS MEASURED AT 17 MG/DL. THE PT WAS REVIVED AND HER BG WAS MEASURED AT 150 MG/DL BEFORE THE PARAMEDICS LEFT HER BEDSIDE. CGM FUNCTIONED ACCORDING TO SPECIFICATIONS, ALERTING PT OF A "LOW" (CGM DOES NOT REPORT VALUES BELOW 40 MG/DL). 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 5015581

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other