BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 4182894 · Received October 17, 2014

    Report

    Report Number
    3004753838-2014-29427
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    September 21, 2014
    Report Date
    September 21, 2014
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADVERSE EVENT OR PROBLEM - ADDITIONAL, ADVERSE EVENT OR PROBLEM - CORRECTION TO REMOVE PRODUCT PROBLEM, DATE OF EVENT - CORRECTION, DATE OF THIS REPORT - CORRECTION, DESCRIBE EVENT OR PROBLEM - CORRECTION, TYPE OF REPORTABLE EVENT - CORRECTION, CORRECTION/ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 TO REPORT ADVERSE EVENT ON (B)(6) 2014. PATIENT CLAIMED THAT AS OF (B)(6) 2014, RECEIVER WOULD NOT TURN ON AND WAS RELYING SOLELY ON BLOOD GLUCOSE VALUES FROM FINGER STICK. PATIENT STATED THAT ON (B)(6) 2014, THEY LOST CONSCIOUSNESS AND WERE VOMITING FROM HIGH BLOOD SUGAR. PATIENT'S MOTHER CALLED THE AMBULANCE AND PATIENT WAS BROUGHT TO THE HOSPITAL. PATIENT DID NOT REPORT ANY FURTHER MEDICAL INTERVENTION AT THE TIME OF CONTACT WITH DEXCOM TECHNICAL SUPPORT.

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 TO REPORT ADVERSE EVENT ON (B)(6) 2014. PATIENT REPORTED THAT THEY LOST CONSCIOUSNESS AND WAS VOMITING FROM HIGH BLOOD SUGAR. PATIENT'S MOTHER CALLED THE AMBULANCE AND PATIENT WAS BROUGHT TO THE HOSPITAL. PATIENT DID NOT REPORT ANY FURTHER MEDICAL INTERVENTION AT THE TIME OF CONTACT WITH DEXCOM TECHNICAL SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662353 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. MT20649

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR