BEUDAMED
    FDA Adverse Event Death Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3841740 · Received May 30, 2014

    Report

    Report Number
    3004753838-2014-05626
    Event Type
    Death
    Date Received
    May 30, 2014
    Date of Event
    April 15, 2014
    Report Date
    May 2, 2014
    Manufacturer
    DEXCOM INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEXCOM G4 PLATINUM CGM RECEIVER WAS RETURNED TO DEXCOM AND RECEIVED IN GOOD CONDITION AND A COMPLETE INVESTIGATION WAS COMPLETED ON (B)(4) 2014. HARDWARE/SOFTWARE INVESTIGATION WAS CONDUCTED AND QUALITY CONTROL REVIEW WAS PERFORMED. RECEIVER SUCCESSFULLY PASSED FUNCTIONAL TESTING. MANUAL AUDIO CHECKS VERIFIED THAT THE SPEAKER AND VIBRATOR WERE FULLY FUNCTIONAL. CORRECT FIRMWARE REVISION 2.0.1.158 WAS INSTALLED. NO NCMRS WERE ASSOCIATED WITH THE LOT NUMBER FOR THIS RECEIVER. THE RESULTS OF THE INVESTIGATION CONFIRMED THAT NO FAULT WAS FOUND WITH THE RECEIVER. REVIEW OF THE RECEIVER DATA CONFIRMED THE DEVICE FUNCTIONED PROPERLY, ALERTING WITH AUDIBLE AND VIBRATORY ALARMS ACCORDING TO SETTINGS. THE SENSOR IN USE AT THE TIME OF THE PATIENT'S DEATH HAD FAILED TWICE UPON ATTEMPTING INITIAL STARTUP ON (B)(6) 2014, AT 09:16AM AND 09:48AM WHICH IS INDICATED BY A WARNING DISPLAYED ON THE RECEIVER. THE PATIENT RESTARTED THE FAILED SENSOR A THIRD TIME AND CONTINUED TO USE IT UNTIL HIS DEATH A DAY LATER WHICH IS AGAINST USER GUIDE INSTRUCTIONS AND CONSTITUTES MISUSE OF THE DEVICE. THE LAST USER INTERACTION WITH THE RECEIVER WAS AT 09:25 PM ON (B)(6) 2014 WHICH WAS THE EVENING PRIOR TO THE PATIENT'S DEATH. DEXCOM'S IN-HOUSE PHYSICIAN HAS ATTEMPTED TO CONTACT THE PATIENT'S PRIMARY CARE PROVIDER TO OBTAIN MORE INFORMATION, BUT WAS UNSUCCESSFUL.

    Description of Event or Problem · 1

    ON (B)(6) 2014 A DEXCOM TERRITORY BUSINESS MANAGER CONTACTED DEXCOM TECHNICAL SUPPORT TO REPORT THAT ONE OF HIS PATIENTS HAD EXPIRED ON (B)(6) 2014. IT IS UNKNOWN IF THE PATIENT WAS USING THE DEXCOM CGM SYSTEM AT THE TIME OF HIS DEATH. THERE ARE VERY FEW DETAILS AVAILABLE REGARDING THE EVENTS LEADING UP TO THE PATIENT'S DEATH AT THIS TIME. DEXCOM HAS MADE NUMEROUS ATTEMPTS TO CONTACT THE FAMILY FOR MORE INFORMATION BUT HAS THUS FAR BEEN UNSUCCESSFUL. THE OFFICIAL CAUSE OF DEATH HAS YET TO BE DETERMINED. DEXCOM ISSUED A RGA TO RETURN THE DEVICE FOR FURTHER INVESTIGATION AND WILL ATTEMPT TO CONTACT THE PATIENT'S PRIMARY CARE PHYSICIAN. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN MORE INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319283 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM INC. MT20649 745148

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Death| O