BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 2024261 · Received March 9, 2011

    Report

    Report Number
    3004753838-2011-00051
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    February 12, 2011
    Report Date
    February 15, 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. THE EXACT AGE OF THIS PT IS NOT REASONABLY KNOWN TO DEXCOM. THE PT'S AGE HAS BEEN ESTIMATED TO BE (B)(4) BASED ON NARRATIVE INFORMATION CONTAINED IN THE PT'S COMPLAINT FILE. THE PT'S AGE IS REPORTED AS AN ESTIMATE PER THE INSTRUCTIONS FOR FORM FDA 3500A.

    Description of Event or Problem · 1

    PT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2011, TO REPORT THAT HE EXPERIENCED INACCURACY IN CGM VALUES DURING AN EXTREME LOW (CGM 80 MG/DL, FINGERSTICK 21 MG/DL). PT FAINTED, AND PARAMEDICS WERE CALLED. PARAMEDICS ATTENDED TO PT, AND PT RECOVERED. PT REPORTED THAT HE WAS FINE BUT TIRED 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 18 YR Other