BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 2002118 · Received February 1, 2011

    Report

    Report Number
    3004753838-2011-00022
    Event Type
    Malfunction
    Date Received
    February 1, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 3, 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)(6) BASED ON NARRATIVE INFO CONTAINED IN THE PT'S COMPLAINT FILE.

    Description of Event or Problem · 1

    PT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2011 TO REPORT THAT SHE EXPERIENCED AN INACCURACY IN CGM READINGS DURING AN EXTREME LOW. PT REPORTED THAT HER CGM WAS READING IN THE 200 MG/DL RANGE WHEN HER LOW OCCURRED. PT BECAME UNCONSCIOUS, AND PARAMEDICS WERE CALLED. PT DOES NOT KNOW WHAT HER BLOOD GLUCOSE READING WAS AT THE TIME SHE BECAME UNCONSCIOUS BUT REPORTED THAT SHE HAD BEEN EXPERIENCING CGM INACCURACIES PRIOR TO THE INCIDENT (CGM >400 MG/DL, FINGERSTICK 225 MG/DL).

    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