BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 4617811 · Received March 19, 2015

    Report

    Report Number
    3004753838-2015-02133
    Event Type
    Malfunction
    Date Received
    March 19, 2015
    Date of Event
    February 23, 2015
    Report Date
    February 23, 2015
    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 RECEIVER WAS NOT RETURNED TO DEXCOM. THE TRANSMITTER (9438-05/66JQW), USED WITH THE COMPLAINT RECEIVER, WAS RETURNED ON (B)(4) 2015. THE RETURNED COMPLAINT TRANSMITTER WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. FUNCTIONAL TESTING WAS PERFORMED AND THE TEST FAILED, CONFIRMING THE REPORTED EVENT OF A PERMANENT OUT OF RANGE SIGNAL. THE ROOT CAUSE WAS DETERMINED TO BE A DEFECTIVE TRANSMITTER.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2015 TO REPORT PERMANENT OUT OF RANGE SIGNAL ON (B)(6) 2015. DEXCOM TECHNICAL SUPPORT HAD THE PATIENT PERFORM A RESET AND THE RESET WAS UNSUCCESSFUL FOR REPORTED ISSUE. THE PATIENT DID NOT REPORT ANY INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187178 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. MT20649-PNK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR