BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM

    MDR report key: 5211597 · Received November 9, 2015

    Report

    Report Number
    3004753838-2015-82002
    Event Type
    Malfunction
    Date Received
    November 9, 2015
    Date of Event
    September 25, 2015
    Report Date
    October 15, 2015
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2015, TO REPORT THAT ON (B)(6) 2015, THEIR RECEIVER LOST APPROXIMATELY THREE WEEKS OF DATA. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. DATA WAS PROVIDED BY THE PATIENT. REVIEW OF THE DATA DID NOT CONFIRM THE REPORTED LOSS OF DATA. THE DEVICE HAS BEEN RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP WILL BE SUBMITTED UPON COMPLETION OF DEVICE ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740259 DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM MDS MDS DEXCOM, INC. MT22495-BLU 5202422

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR