BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 2063873 · Received April 11, 2011

    Report

    Report Number
    3004753838-2011-00099
    Event Type
    Malfunction
    Date Received
    April 11, 2011
    Date of Event
    March 15, 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'S WIFE CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2011 TO REPORT THAT HER HUSBAND EXPERIENCED AN INACCURACY IN CGM READINGS DURING AN EXTREME LOW (CGM 148 MG/DL, BG 24 MG/DL). PT'S WIFE WOKE UP IN THE MIDDLE OF THE NIGHT AND DISCOVERED THAT PT WAS SWEATING AND CLENCHING HIS TEETH. PT'S WIFE CALLED PARAMEDICS, AND PARAMEDICS TREATED PT WITH AN IV. PT WAS FINE AT THE TIME OF HIS WIFE'S 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 5012442

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| O