BEUDAMED
    FDA Adverse Event Death Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 5054782 · Received September 3, 2015

    Report

    Report Number
    3004753838-2015-80885
    Event Type
    Death
    Date Received
    September 3, 2015
    Date of Event
    June 29, 2015
    Report Date
    August 6, 2015
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE RECEIVER BEING USED AT THE TIME OF EVENT WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. FUNCTIONAL TESTING WAS PERFORMED AND THERE WERE NO DEFECTS FOUND. A REVIEW OF THE DOWNLOADED RECEIVER LOG DID NOT FIND ANY ERRORS. THE DEVICE WAS DETERMINED TO BE OPERATING WITHIN THE REQUIRED SPECIFICATIONS. THERE WAS NO ALLEGED MALFUNCTION TO THE DEVICE.

    Description of Event or Problem · 1

    PATIENT'S BROTHER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2015, TO STATE THE PATIENT PASSED AWAY ON (B)(6) 2015. REPORTEDLY, THE PATIENT HAD BEEN IN A NURSING HOME FOR FOUR MONTHS AND HAD PNEUMONIA. ON (B)(6) 2015, A NURSE IN THE NURSING HOME NOTICED THAT THE PATIENT'S FINGER NAILS WERE BLUE. THE PATIENT WAS TRANSPORTED TO THE NEAREST HOSPITAL THE SAME DAY AND EXPIRED WHILE IN THE HOSPITAL TWO DAYS LATER. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    PATIENT'S BROTHER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2015, TO STATE THE PATIENT PASSED AWAY ON (B)(6) 2015. REPORTEDLY, THE PATIENT HAD BEEN IN A NURSING HOME FOR FOUR MONTHS AND HAD PNEUMONIA. ON (B)(6) 2015 A NURSE IN THE NURSING HOME NOTICED THAT THE PATIENT'S FINGER NAILS WERE BLUE. THE PATIENT WAS TRANSPORTED TO THE NEAREST HOSPITAL THE SAME DAY AND EXPIRED WHILE IN THE HOSPITAL TWO DAYS LATER. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. THE TRANSMITTER 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 THERE WAS NO FAILURE DETECTED. THE DEVICE WAS DETERMINED TO BE OPERATING WITHIN THE REQUIRED SPECIFICATIONS. THERE WAS NO ALLEGED MALFUNCTION TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586636 DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. MT20649-BLU 5191148

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Death| H