BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 2062675 · Received April 11, 2011

    Report

    Report Number
    3004753838-2011-00102
    Event Type
    Injury
    Date Received
    April 11, 2011
    Date of Event
    March 18, 2011
    Report Date
    March 24, 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 HE EXPERIENCED AN INACCURACY IN CGM READINGS DURING AN EXTREME LOW (CGM 79 MG/DL, BG 35MG/DL). PT HAD LOW ALERT SET AT 80 MG/DL AND REPORTED THAT HE DID NOT HEAR THE ALARM. PT REPORTED THAT HE HAD A SEIZURE AND THAT PARAMEDICS WERE CALLED. PARAMEDICS ADMINISTERED GLUCAGON, AND PT RECOVERED. PT WAS FINE AT THE TIME OF HIS 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

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other