BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3959081 · Received July 28, 2014

    Report

    Report Number
    3004753838-2014-05845
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    March 17, 2013
    Report Date
    March 17, 2013
    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 7/9/2014. THE COMPLAINT OF HARDWARE ERROR IS CONFIRMED. THE ROOT CAUSE WAS DETERMINED TO BE HARDWARE ERROR CODE FAILURE. THE TRANSMITTER (PART 9438-01/SERIAL NO. (B)(4)), THAT WAS BEING USED WITH THE RECEIVER DURING THE REPORTED EVENT OF HARDWARE ERROR WAS RETURNED. EVALUATION OF THE RETURNED TRANSMITTER DID NOT CONFIRM THE REPORTED EVENT. THERE WAS NO DEFECT FOUND.

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2013 TO REPORT A HARDWARE ERROR CODE PATIENT EXPERIENCED ON (B)(6) 2013. 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
    438393 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. MT20649

    Patients

    Seq Age Sex Outcome Treatment
    1 Other