BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 4241735 · Received November 10, 2014

    Report

    Report Number
    3004753838-2014-29527
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    October 15, 2014
    Report Date
    October 15, 2014
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CLINIC REPRESENTATIVE CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 ON PATIENT'S BEHALF TO REPORT AN ADVERSE EVENT ON (B)(6) 2014. PATIENT CLAIMS THAT SHE EXPERIENCED A HYPOGLYCEMIC EVENT WHILE DRIVING AND BECAME INVOLVED IN A CAR ACCIDENT. PATIENT WAS IN THE ER ON (B)(6) 2014. CLINIC REPRESENTATIVE DID NOT REPORT ANY FURTHER MEDICAL INTERVENTION AT TIME OF CONTACT WITH DEXCOM TECHNICAL SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723921 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-27

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other