BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 4222179 · Received November 3, 2014

    Report

    Report Number
    3004753838-2014-29486
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 6, 2014
    Report Date
    October 6, 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 RETURNED COMPLAINT DEVICE WAS VISUALLY INSPECTED AND A BENT NEEDLE THAT IS PARTIALLY EXPOSED ON THE SIDE OF THE APPLICATOR WAS OBSERVED. HOWEVER, DEXCOM IS UNABLE TO FULLY PERFORM AN INVESTIGATION TO DETERMINE THE CAUSE OF FAILURE DUE TO THE SENSOR WIRE NOT BEING RETURNED.

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 AND CLAIMED THAT ON (B)(6) 2014, UPON REMOVAL OF SENSOR POD, PATIENT WAS UNABLE TO LOCATE SENSOR WIRE. PATIENT DID NOT REPORT ANY INJURY OR MEDICAL INTERVENTION AT THE TIME OF CONTACT WITH DEXCOM TECHNICAL SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702213 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-27 5190583

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR