BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 4842466 · Received June 12, 2015

    Report

    Report Number
    3004753838-2015-04903
    Event Type
    Malfunction
    Date Received
    June 12, 2015
    Date of Event
    May 19, 2015
    Report Date
    May 20, 2015
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SUBSEQUENT TO THE INITIAL MDR, THE COMPLAINT RECEIVER WAS NOT RETURNED TO DEXCOM. THE TRANSMITTER ((B)(4)/LOT NUMBER 5191423), BEING USED WITH THE COMPLAINT RECEIVER, WAS RETURNED ON (B)(6) 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 TRANSMITTER.

    Additional Manufacturer Narrative · 1

    (B)(4). COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION. THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED, THEREFORE A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. IT WAS REPORTED THAT A PEDIATRIC PATIENT WAS USING THE COMPLAINT DEVICE. IT SHOULD BE NOTED THAT THE DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM USER'S GUIDE STATES: THE DEXCOM G4 SYSTEM IS NOT APPROVED FOR USE IN CHILDREN OR ADOLESCENTS, PREGNANT WOMEN OR PERSONS ON DIALYSIS.

    Description of Event or Problem · 1

    PATIENT'S MOTHER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2015 TO REPORT THAT ON (B)(6) 2015, PATIENT EXPERIENCED A PERMANENT OUT OF RANGE SIGNAL. PEDIATRIC PATIENT USES ADULT DEVICE AGAINST USER GUIDE RECOMMENDATIONS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384287 DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. MT20649-BLU 5199110

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR