BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 2220626 · Received July 14, 2011

    Report

    Report Number
    3004753838-2011-00210
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    March 1, 2011
    Report Date
    June 14, 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 06/14/2011 TO REPORT THAT A CGM INACCURACY HAD OCCURRED ON (B)(6) 2011. PT DOES NOT RECALL CGM'S READING AT THE TIME NOR DOES HE REMEMBER HIS ACTUAL BG LEVELS. ALTHOUGH PT'S LOW ALERT WAS SET AT 100 MG/DL, PT REPORTS THAT CGM DID NOT ALERT HIM OF AN EXTREME LOW WHEN HE EXPERIENCED A HYPOGLYCEMIC EPISODE. PT BECAME DISORIENTED, LOST CONSCIOUSNESS AND HAD TO BE HOSPITALIZED OVERNIGHT. RECEIVER DATA FOR (B)(4) 2011 WAS NO LONGER AVAILABLE FOR REVIEW. HOWEVER, DATA FROM SUBSEQUENT DATES SHOWED THAT THE SENSOR WAS BEING REUSED INCONSISTENT WITH PRODUCT'S LABEL RECOMMENDATION, FOR MULTIPLE SESSIONS, AND THAT IT WAS NOT BEING CALIBRATED EVERY 12 HRS. PT WAS FINE AT THE TIME OF HIS CALL TO DEXCOM.

    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 51 YR Hospitalization| O