BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3831081 · Received May 23, 2014

    Report

    Report Number
    3004753838-2014-08249
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    April 26, 2014
    Report Date
    April 29, 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

    Description of Event or Problem · 1

    PATIENT'S FATHER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 TO REPORT A HYPOGLYCEMIC EVENT AND CGM INACCURACIES ON (B)(6) 2013. AT THE TIME OF THE HYPOGLYCEMIC EVENT, THE PATIENT'S FATHER REPORTED THAT PATIENT'S CGM WAS READING 72 MG/DL RANGE AND HIS BLOOD GLUCOSE METER WAS READING 25 MG/DL; AT WHICH TIME, THE PATIENT'S FATHER GAVE PATIENT A GLUCAGON INJECTION. PATIENT'S FATHER REPORTED PATIENT PASSED OUT FOR ABOUT 30 SECONDS. PATIENT'S FATHER REPORTED 2 MINUTES AFTER GLUCAGON INJECTION THE PATIENT'S BLOOD GLUCOSE METER WAS READING 55 MG/DL. PATIENT'S FATHER CONTACTED 911. WHEN 911 ARRIVED PATIENT'S BLOOD GLUCOSE WAS AT 98 MG/DL. AT THE TIME OF THE CALL TO DEXCOM TECHNICAL SUPPORT, THE PATIENT'S FATHER STATED THAT THE PATIENT WAS OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308071 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-27 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Other