BEUDAMED
    FDA Adverse Event Death Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM

    MDR report key: 5749808 · Received June 25, 2016

    Report

    Report Number
    3004753838-2016-03515
    Event Type
    Death
    Date Received
    June 25, 2016
    Date of Event
    May 22, 2016
    Report Date
    May 26, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000170
    PMA / PMN Number
    P120005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) DESCRIBE EVENT OR PROBLEM - ADDITIONAL, ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF DEATH.

    Description of Event or Problem · 1

    THE RECEIVER (PART NUMBER STK-DR-BLU/SERIAL NUMBER (B)(4)/LOT NUMBER 5198414) BEING USED AT THE TIME OF EVENT WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECTS WERE FOUND. FUNCTIONAL TESTING WAS PERFORMED AND THE TEST PASSED. THE DATA LOG WAS DOWNLOADED AND REVIEWED AND FOUND NO OBSERVATIONS RELATED TO THE EVENT. ADDITIONALLY, TWO TRANSMITTERS (LOT NUMBER 5210724 AND LOT NUMBER 5197155) WERE RETURNED FOR EVALUATION. THE PRODUCTS WERE VISUALLY INSPECTED AND NO DEFECTS WERE FOUND. FUNCTIONAL TESTING WAS PERFORMED AND BOTH TESTS PASSED. THERE WAS NO ALLEGED MALFUNCTION REPORTED FOR THE RETURNED DEVICES. NO FURTHER PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    PATIENT'S WIFE CONTACTED DEXCOM ON 05/26/2016 TO REPORT THAT HER HUSBAND HAD PASSED AWAY ON (B)(6) 2016. PATIENT'S WIFE STATED THAT THE PATIENT WAS AT THE MOVIE THEATERS WHEN HE FELL OVER. SOMEONE (UNKNOWN) NOTICED AND CALLED 911. THE PATIENT WAS RUSHED TO THE HOSPITAL. WIFE WAS UNSURE WHAT MEDICATIONS WERE ADMINISTERED IF ANY. WIFE IS UNDER THE IMPRESSION THE PATIENT WAS UNRESPONSIVE THE ENTIRE TIME. PATIENT WAS WEARING THE CONTINUOUS GLUCOSE MONITOR (CGM) AT TIME OF DEATH. HOWEVER, THERE WAS NO ALLEGED DEVICE MALFUNCTION. NO PRODUCT OR DATA RETURNED FOR INVESTIGATION, HOWEVER, A DEATH CERTIFICATE WAS PROVIDED WHICH CONFIRMED THE EVENT. ROOT CAUSE WAS DETERMINED TO BE CARDIAC ARREST AND CORONARY ARTERY DISEASE. DIABETES MELLITUS WAS ANOTHER CONDITION WHICH CONTRIBUTED TO DEATH. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403772 DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM MDS MDS DEXCOM, INC. MT22495-BLU 5198414 00386270000170

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death