BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 1963491 · Received January 10, 2011

    Report

    Report Number
    3004753838-2011-00013
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    December 2, 2010
    Report Date
    December 2, 2010
    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) 2010 TO REPORT THAT HE EXPERIENCED A CGM ERROR LEADING TO UNCONSCIOUSNESS AND SEIZURE. PT FELL ASLEEP AFTER RECEIVING AN ERROR CODE. PT'S BLOOD GLUCOSE DROPPED TO 16 MG/DL IN THE MIDDLE OF THE NIGHT, BUT HIS CGM DID NOT ALERT HIM. PT LOST CONSCIOUSNESS AND HAD A SEIZURE. HIS WIFE GAVE HIM A GLUCAGON SHOT, AND HE WAS THEN TAKEN TO THE HOSP. PT WAS STABLE AT THE TIME OF HIS CALL TO DEXCOM TECHNICAL SUPPORT BUT INDICATED THAT HE DID NOT FEEL WELL AND THAT HIS MUSCLES WERE TENSE FROM THE SEIZURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR MDS DEXCOM, INC. 9500-03 5009892

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other