BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 5241737 · Received November 21, 2015

    Report

    Report Number
    3004753838-2015-63311
    Event Type
    Malfunction
    Date Received
    November 21, 2015
    Date of Event
    November 2, 2015
    Report Date
    November 2, 2015
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000040
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM ON (B)(6) 2015, TO REPORT THAT ON (B)(6) 2015 THEIR TRANSMITTER WAS OUT OF RANGE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771768 DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9438-01 5191263 00386270000040

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR