BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3830195 · Received May 23, 2014

    Report

    Report Number
    3004753838-2014-04627
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    April 26, 2014
    Report Date
    April 26, 2014
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) THE INITIAL REPORT STATES THAT REVIEW OF THE DATA CONFIRMED THAT THE DEVICE WAS WORKING ACCORDING TO SPECIFICATION HOWEVER, EVALUATION OF THE RETURNED DEVICE CONFIRMED THE REPORTED NO AUDIO OUTPUT.

    Description of Event or Problem · 1

    PATIENT AND PATIENT'S WIFE CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 AND CLAIMED NO AUDIO OUTPUT PRIOR TO A HYPERGLYCEMIC EVENT IN WHICH THE PATIENT WAS FOUND UNCONSCIOUS BY HIS WIFE ON (B)(6) 2014. AT THE TIME OF THE HYPOGLYCEMIC EVENT, PATIENT'S WIFE ADMINISTERED ONE SHOT OF GLUCAGON AND CALLED PARAMEDICS. PATIENT'S WIFE TESTED PATIENT'S BLOOD GLUCOSE WHICH WAS 33 MG/DL AT THE TIME OF THE HYPOGLYCEMIC EVENT. UPON ARRIVAL PARAMEDICS TESTED THE PATIENT'S BLOOD GLUCOSE AT 42 MG/DL. ON (B)(6) 2014, PATIENT RECEIVED TWO ADDITIONAL SHOTS OF GLUCAGON AT THE HOSPITAL. AT THE TIME OF THE CALL TO DEXCOM TECHNICAL SUPPORT, PATIENT'S WIFE REPORTED THAT THE PATIENT WAS DISTRAUGHT AND ANXIOUS BUT IN GOOD CONDITION. ADDITIONALLY, AT THE TIME OF THE CALL, DEXCOM TECHNICAL SUPPORT ADVISED PATIENT'S WIFE TO TEST ALERT FUNCTIONALITY AND PATIENT'S WIFE CLAIMED ALERTS WERE NOT FUNCTIONING AT THE TIME OF THE CALL. DEXCOM HAS ISSUED AN RGA FOR PATIENT TO RETURN THE DEVICE TO BE INVESTIGATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307610 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. MT20649 5131276

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other