BEUDAMED
    FDA Adverse Event Death Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 5258607 · Received December 1, 2015

    Report

    Report Number
    3004753838-2015-82386
    Event Type
    Death
    Date Received
    December 1, 2015
    Date of Event
    November 5, 2015
    Report Date
    November 6, 2015
    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).

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM ON 11/06/2015, TO REPORT A PATIENT HOSPITALIZATION THAT OCCURRED ON (B)(6) 2015. PATIENT REPORTED WEARING DEXCOM CONTINUOUS GLUCOSE MONITOR (CGM) AT THE TIME OF THE EVENT. PATIENT STATED THAT THE DEXCOM DEVICE DID NOT MALFUNCTION AND HE WAS NOT EXPERIENCING ANY CURRENT ISSUES WITH PERFORMANCE. ADDITIONALLY, PATIENT REPORTED THAT ALARMS WORKED PROPERLY. PATIENT REPORTED THAT HE CALLED 911, AND WAS ADMITTED TO THE HOSPITAL FOR DIABETIC KETOACIDOSIS (DKA). PATIENT REPORTED BLOOD GLUCOSE (BG) LEVEL WAS AT 500MG/DL AT TIME OF HOSPITAL ADMISSION. PATIENT REPORTED THAT HE WAS ADMINISTERED AN INTRAVENOUS (IV) SALINE DRIP. AT THE TIME OF CONTACT, PATIENT REPORTED THAT HE IS STILL CURRENTLY IN THE HOSPITAL, FEELING PHYSICALLY WEAK, BUT OTHERWISE OK. ADDITIONALLY, PATIENT REPORTED THAT UPON HOSPITAL ADMISSION, THE DOCTORS REMOVED TRANSMITTER AND THREW IT IN THE TRASH. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. THERE WAS NO ALLEGED DEVICE MALFUNCTION. THE COMPLAINT STATES THAT THE PATIENT WAS HOSPITALIZED AS A RESULT OF DIABETIC KETOACIDOSIS (DKA). IT SHOULD BE NOTED THAT DIABETES MELLITUS IS A KNOWN CAUSE OF DKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788830 DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. UNKNOWN NI

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Hospitalization| O