BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE SYSTEM

    MDR report key: 5054938 · Received September 3, 2015

    Report

    Report Number
    3004753838-2015-85300
    Event Type
    Malfunction
    Date Received
    September 3, 2015
    Date of Event
    August 12, 2015
    Report Date
    August 12, 2015
    Manufacturer
    DEXCOM, INC.
    Product Code
    OYC
    UDI-DI
    00386270000019
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 TECHNICAL SUPPORT ON (B)(6) 2015 TO REPORT CONTINUOUS GLUCOSE MONITORING (CGM) INACCURACIES COMPARED TO BLOOD GLUCOSE (BG) METER THAT OCCURRED ON (B)(6) 2015. SENSOR WAS INSERTED ON (B)(6) 2015. AT THE TIME OF CONTACT, NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MDR, THE COMPLAINT SENSOR WAS NOT RETURNED TO DEXCOM. THE TRANSMITTER (PART NUMBER STT-GL-003/SERIAL NUMBER (B)(4)/LOT NUMBER 5201339), BEING USED WITH THE COMPLAINT SENSOR, WAS RETURNED ON (B)(6) 2015. THE RETURNED TRANSMITTER WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. FUNCTIONAL TESTING WAS PERFORMED AND THERE WAS NO FAILURE DETECTED. BECAUSE THE RETURNED PRODUCT IS UNRELATED TO THE CUSTOMER COMPLAINT, THE REPORTED EVENT OF INACCURACIES COULD NOT BE CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583872 ANIMAS VIBE SYSTEM OYC OYC DEXCOM, INC. 9500-27 5201054 00386270000019

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR