BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 5211663 · Received November 9, 2015

    Report

    Report Number
    3004753838-2015-63029
    Event Type
    Malfunction
    Date Received
    November 9, 2015
    Date of Event
    October 15, 2015
    Report Date
    October 15, 2015
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000224
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM ON 10/15/2015 TO REPORT THAT ON 10/15/2015, PATIENT EXPERIENCED A LOSS OF CONNECTION. DEXCOM REPRESENTATIVE ADVISED PATIENT THAT THE DEVICE WOULD REGAIN CONNECTION WITHIN 15 MINUTES. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740661 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9438-06 5204609 00386270000224

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR