BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 2091139 · Received May 9, 2011

    Report

    Report Number
    3004753838-2011-00139
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    January 1, 2011
    Report Date
    April 18, 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 UNKNOWN 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

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2011 TO REPORT THAT HE EXPERIENCED INACCURACY IN CGM READINGS. PATIENT STATED THAT HIS CGM WAS READING OVER 400 MG/DL, BUT HE DID NOT HAVE HIS BG METER TO CONFIRM THE READING SO HE TREATED HIMSELF WITH INSULIN. PATIENT SUBSEQUENTLY EXPERIENCED A HYPOGLYCEMIC EVENT AND LOST CONSCIOUSNESS. PATIENT'S GIRLFRIEND CALLED THE PARAMEDICS, WHO ADMINISTERED A DEXTROSE IV. PATIENT STATED THAT, ACCORDING TO THE PARAMEDICS, HIS BG WAS AT 22 MG/DL OR 18 MG/DL WHEN THEY ARRIVED. PATIENT REGAINED CONSCIOUSNESS AFTER RECEIVING DEXTROSE, AND NO FOLLOW UP MEDICAL TREATMENT WAS REQUIRED. PATIENT REPORTED HE WAS NOT EXPERIENCING ANY OTHER SYMPTOMS 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 35 YR Other