BEUDAMED
    FDA Adverse Event Death Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 5995108 · Received October 3, 2016

    Report

    Report Number
    3004753838-2016-80488
    Event Type
    Death
    Date Received
    October 3, 2016
    Date of Event
    August 18, 2016
    Report Date
    September 6, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON 09/06/2016, THAT ON (B)(6) 2016, THE PATIENT PASSED AWAY. PATIENT'S MOTHER-IN-LAW INITIALLY CONTACTED DEXCOM REGARDING POSSIBLE RETURN OR DONATION OF CONTINUOUS GLUCOSE MONITORING (CGM) EQUIPMENT. CONTACT WAS MADE WITH THE PATIENT'S HUSBAND WHO PROVIDED FURTHER DETAILS REGARDING THE PATIENT'S DEATH. THE PATIENT WAS RUSHED TO THE HOSPITAL BY HER HUSBAND, DUE TO HAVING A LOW BLOOD GLUCOSE (BG) LEVEL OF 12MG/DL. PATIENT EXPERIENCED COMPLICATIONS DUE TO THE LOW BG AND WAS ASPIRATED. IT WAS ALSO INDICATED THAT THE PATIENT HAD PANCREATITIS. THE PATIENT WAS NOT WEARING THE CGM AT THE TIME OF THE EVENT. SHE HAD NOT BEEN WEARING THE DEVICE FOR SEVERAL DAYS IN ORDER TO HEAL HER SITE, DUE TO SCAR TISSUE. PATIENT'S HUSBAND REPORTED THAT THE CAUSE OF DEATH WAS COMPLICATIONS WITH DIABETES AND WAS NOT RELATED TO THE DEXCOM CGM. 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
    645472 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR MDS DEXCOM, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Death| H| O