BEUDAMED
    FDA Adverse Event Death Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 6358312 · Received February 24, 2017

    Report

    Report Number
    3004753838-2017-10962
    Event Type
    Death
    Date Received
    February 24, 2017
    Date of Event
    January 9, 2017
    Report Date
    February 2, 2017
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    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).

    Additional Manufacturer Narrative · 1

    (B)(4). DIABETES MELLITUS IS A KNOWN RISK FACTOR FOR DEVELOPING PERITONSILLAR ABSCESS.

    Description of Event or Problem · 1

    THE RECEIVER (PART NUMBER STK-GL-001/SERIAL NUMBER (B)(4)/LOT NUMBER 5190868) BEING USED AT THE TIME OF EVENT OF RETURNED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED AND NO DEFECTS WERE FOUND. FUNCATIONAL TESTING WAS PERFORMED AND NO FAILURES WERE DETECTED. A REVIEW OF THE DOWNLOADED DATA LOG DID NOT FIND ANY ERRORS. ADDITIONALLY, THE TRANSMITTER (PART NUMBER STT-GL-003/SERIAL NUMBER (B)(4)/LOT NUMBER 5210724) WAS ALSO RETURNED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED AND NO DEFECTS WERE FOUND. FUNCTIONAL TESTING WAS PERFORMED AND NO FAILURES WERE DETECTED. VOLTAGE TESTING WAS PERFORMED AND THE TRANSMITTER HAS VOLTAGE. THE DEVICES WERE DETERMINED TO BE OPERATING WITHIN THE REQUIRED SPECIFICATIONS WITHOUT MALFUNCTION. THERE WAS NO ALLEGED MALFUNCTION TO THE RETURN DEVICES.

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON (B)(6) 2017 THAT ON (B)(6) 2017, THE PATIENT WAS HOSPITALIZED AND THEN LATER PASSED AWAY ON (B)(6) 2017. PATIENT'S WIFE REPORTED THAT THE CAUSE OF DEATH WAS CAUSED BY AN ABSCESS IN THE THROAT THAT PREVENTED PATIENT FROM EATING. PATIENT'S WIFE REPORTED THAT THE PATIENT HAD BEEN DIAGNOSED WITH ABSCESS. PATIENT WAS HOSPITALIZED FOR FIVE (5) DAYS. PATIENT WAS TREATED WITH ANTIBIOTICS. PATIENT WAS THEN TAKEN TO A HOSPICE FOR "A COUPLE OF DAYS," THEN TAKEN HOME. PATIENT'S WIFE REPORTED THAT THE PATIENT WAS UNDER 24-HOUR CARE AT HOME. PATIENT'S WIFE CALLED PARAMEDICS BECAUSE THE PATIENT WAS NOT EATING FOR A "FEW DAYS." PATIENT WAS TRANSPORTED TO HOSPITAL. PATIENT WAS TREATED BY WITH ANTIBIOTICS, THEN RETURNED HOME "IN A FEW DAYS." THE NAME OF THE ANTIBIOTICS AND DATES OF HOSPITALIZATION ARE UNKNOWN. IT'S NOT KNOWN WHERE PATIENT PASSED AWAY. PATIENT WAS WEARING THE CONTINUOUS GLUCOSE MONITOR (CGM) AT THE TIME OF DEATH. THERE WAS NO ALLEGED DEVICE MALFUNCTION. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WAS RETURNED FOR EVALUATION. A CERTIFICATE OF DEATH WAS NOT PROVIDED. THE REPORTED EVENT OF DEATH COULD NOT BE CONFIRMED. A ROOT CAUSE COULD NOT BE VERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139222 DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR MDS DEXCOM, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death| H| O ANTIBIOTICS, UNKNOWN| STEROIDS, UNKNOWN