BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 4753096 · Received May 6, 2015

    Report

    Report Number
    3004753838-2015-14188
    Event Type
    Malfunction
    Date Received
    May 6, 2015
    Date of Event
    April 8, 2015
    Report Date
    April 8, 2015
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION; HOWEVER, THE DATA LOG WAS PROVIDED BY THE PATIENT. IT WAS DOWNLOADED AND REVIEWED ON (B)(4) 2015 AND CONFIRMED THE REPORTED EVENT OF INACCURATE BG VALUES. IT WAS REPORTED THAT THE PATIENT DID NOT INSERT THE SENSOR IN AN APPROVED SITE ACCORDING TO THE USER'S GUIDE. IT SHOULD BE NOTED THAT THE DEXCOM G4® PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM USER'S GUIDE STATES: SENSOR PLACEMENT AND INSERTION IS NOT APPROVED FOR SITES OTHER THAN THE BELLY (ABDOMEN).

    Additional Manufacturer Narrative · 1

    (B)(4). SUBSEQUENT TO THE INITIAL MDR, THE COMPLAINT SENSOR WAS NOT RETURNED TO DEXCOM. THE TRANSMITTER DEVICE ((B)(4)/LOT NUMBER 5191576), BEING USED WITH THE COMPLAINT SENSOR, WAS RETURNED ON (B)(6) 2015. THE RETURNED COMPLAINT TRANSMITTER WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. FUNCTIONAL TESTING WAS PERFORMED AND THE REPORTED FAULT COULD NOT BE REPRODUCED AND THERE WAS NO FAILURE DETECTED. THE DEVICE WAS DETERMINED TO BE OPERATING WITHIN THE REQUIRED SPECIFICATIONS WITHOUT MALFUNCTION. EVALUATION OF THE RETURNED TRANSMITTER DID NOT CONFIRM THE REPORTED EVENT OF INACCURATE BLOOD GLUCOSE VALUES.

    Description of Event or Problem · 1

    PATIENT'S MOTHER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2015 TO REPORT CONTINUOUS GLUCOSE MONITOR (CGM) INACCURACY COMPARED TO BLOOD GLUCOSE (BG) METER ON (B)(6) 2015. SENSOR WAS INSERTED ON (B)(6) 2015. SENSOR WAS INSERTED IN THE ARM. PATIENT'S MOTHER DID NOT REPORT ANY INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296974 DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-27 5197465

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR