BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 2101900 · Received May 2, 2011

    Report

    Report Number
    3004753838-2011-00125
    Event Type
    Malfunction
    Date Received
    May 2, 2011
    Date of Event
    March 31, 2011
    Report Date
    April 4, 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 DURING AN EXTREME LOW. PATIENT DOSED OFF THE INACCURATE READING, WHICH LED TO EXTREME CONFUSION BUT NO SEIZURES OR UNCONSCIOUSNESS. PARAMEDICS WERE CALLED AND ADMINISTERED GLUCAGON. PATIENT REPORTED FEELING SORE, EXHAUSTED, AND WEAK AT THE TIME OF HIS CALL TO DEXCOM TECHNICAL SUPPORT. DURING A FOLLOW-UP CALL MADE BY DEXCOM TECHNICAL SUPPORT A FEW DAYS LATER, PATIENT NOTED THAT HIS CONDITION HAD IMPROVED.

    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 Other