BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM PEDIATRIC CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 5287385 · Received December 10, 2015

    Report

    Report Number
    3004753838-2015-63791
    Event Type
    Malfunction
    Date Received
    December 10, 2015
    Date of Event
    November 17, 2015
    Report Date
    November 22, 2015
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM ON (B)(6) 2015 TO REPORT THAT ON (B)(6) 2015, PATIENT EXPERIENCED A PERMANENT OUT OF RANGE SIGNAL. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. IT WAS REPORTED THAT AN ADULT PATIENT WAS USING A PEDIATRIC RECEIVER. IT SHOULD BE NOTED THAT THE DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM USER'S GUIDE STATES: THE DEXCOM G4 PLATINUM (PEDIATRIC) CONTINUOUS GLUCOSE MONITORING SYSTEM IS A GLUCOSE MONITORING DEVICE INDICATED FOR DETECTING TRENDS AND TRACKING PATTERNS IN PERSONS AGES (B)(6) YEARS WITH DIABETES.

    Description of Event or Problem · 1

    THE COMPLAINT RECEIVER WAS NOT RETURNED TO DEXCOM. THE TRANSMITTER (PART NUMBER STT-GL-003/SERIAL NUMBER (B)(4)/LOT NUMBER 5201918), BEING USED WITH THE COMPLAINT RECEIVER, WAS RETURNED ON 12/15/2015. THE RETURNED TRANSMITTER WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. FUNCTIONAL TESTING WAS PERFORMED AND THE TEST FAILED. THE REPORTED EVENT OF A PERMANENT OUT OF RANGE SIGNAL WAS CONFIRMED. THE ROOT CAUSE WAS DETERMINED TO BE A DEFECTIVE TRANASMITTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    816039 G4 PLATINUM PEDIATRIC CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. MT22430-BLU 5196156

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR