BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 4201090 · Received October 27, 2014

    Report

    Report Number
    3004753838-2014-31335
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    September 27, 2014
    Report Date
    September 28, 2014
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEXCOM REVIEWED RECEIVER DATA ON 10/15/2014. THERE WERE INDICATIONS OF GAPS IN TRANSMISSION. A CAPA HAS BEEN INITIATED FOR THIS ISSUE.

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 TO REPORT AN INTERMITTENT OUT OF RANGE SIGNAL ON (B)(6) 2014. AT THE TIME OF CONTACT WITH DEXCOM TECHNICAL SUPPORT, NO MEDICAL INTERVENTION OR INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681365 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9438-01

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR