BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3945498 · Received July 21, 2014

    Report

    Report Number
    3004753838-2014-05814
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 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). THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. EVALUATION OF THE DEVICE WAS UNABLE TO CONFIRM THE REPORTED BROKEN SENSOR WIRE.

    Description of Event or Problem · 1

    DISTRIBUTOR CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 TO REPORT THAT ON (B)(6) 2014 PATIENT EXPERIENCED A POSSIBLE BROKEN SENSOR WIRE UPON REMOVAL OF THE TRANSMITTER. PATIENT DID NOT REPORT ANY INJURY OR ANY MEDICAL INTERVENTION AT THE TIME OF CONTACT WITH DEXCOM TECHNICAL SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424327 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-27 5131300

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other