BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3951442 · Received July 22, 2014

    Report

    Report Number
    3004753838-2014-24579
    Event Type
    Injury
    Date Received
    July 22, 2014
    Date of Event
    June 21, 2014
    Report Date
    June 25, 2014
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 TO REPORT DEHYDRATION AND CGM INACCURACY COMPARED TO BLOOD GLUCOSE METER ON (B)(6) 2014. PATIENT STATED THEY WERE FEELING SLUGGISH AND WENT TO THE HOSPITAL. PATIENT WAS TOLD THEY WERE DEHYDRATED AND WAS PUT ON AN IV AND ADMINISTERED INSULIN. AT THE TIME OF CONTACT WITH DEXCOM TECHNICAL SUPPORT PATIENT WAS DOING OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428981 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-27 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other