BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 2202297 · Received August 2, 2011

    Report

    Report Number
    3004753838-2011-00230
    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 HE HAD EXPERIENCED A SEIZURE CAUSED BY A HYPOGLYCEMIC EVENT WHICH WAS TRIGGERED BY PT'S REPEATED INTAKE OF INSULIN, BASING HIS TREATMENT DECISIONS SOLELY ON READINGS OF HIS CGM, WITHOUT MEASURING HIS BG A SINGLE TIME. ON THE MORNING OF (B)(6) 2011, PT WORK UP TO CGM READING 297 MG/DL AND DECIDED TO TAKE 6.1 UNITS OF INSULIN, WENT BACK TO BED, WOKE UP TO A CGM READING OF 300 MG/DL AND TOOK 8.6 UNITS OF INSULIN. LASTLY HE WORK UP TO A CGM READING APPROXIMATELY 300 MG/DL AGAIN AND DECIDED TO TAKE 10.5 UNITS OF INSULIN. PT DOESN'T REMEMBER MUCH AFTER THIS BUT WAKING UP TO PARAMEDICS. HIS GIRLFRIEND HAD BEEN TRYING TO TREAT HIM WITH JUICE AND GEL BUT WAS UNSUCCESSFUL. PT HAS BEEN ADVISED TO CONFIRM HIS BG LEVELS BEFORE MAKING THERAPEUTIC ADJUSTMENTS. AT THE TIME OF HIS 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 5015544

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other