BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE SYSTEM

    MDR report key: 5022660 · Received August 21, 2015

    Report

    Report Number
    3004753838-2015-85203
    Event Type
    Malfunction
    Date Received
    August 21, 2015
    Date of Event
    July 30, 2015
    Report Date
    August 3, 2015
    Manufacturer
    DEXCOM, INC.
    Product Code
    OYC
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT SENSOR DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, THE TRANSMITTER (PART NUMBER STT-GL-004/SERIAL NUMBER (B)(4)/LOT NUMBER 5191818) BEING USED WITH THE SENSOR WAS RETURNED TO ANIMAS FOR EVALUATION. DEVICE EVALUATION WAS COMPLETED BY ANIMAS ON (B)(4) 2015. INVESTIGATION RESULTS WERE RECEIVED BY DEXCOM ON (B)(4) 2015. THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO COSMETIC FLAW. 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. THE REPORTED EVENT OF AN INTERMITTENT OUT OF RANGE SIGNAL WAS NOT CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    DISTRIBUTOR CONTACTED DEXCOM TECHNICAL SUPPORT ON BEHALF OF PATIENT 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

    THE TRANSMITTER (PART NUMBER STT-GL-004/SERIAL NUMBER (B)(4)/LOT NUMBER 5191818), RETURNED TO DEXCOM FOR EVALUATION. THE 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. THE REPORTED EVENT OF INACCURACIES WAS NOT CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556008 ANIMAS VIBE SYSTEM OYC OYC DEXCOM, INC. 9500-35 5201652

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR