BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 6194057 · Received December 21, 2016

    Report

    Report Number
    2531779-2016-34465
    Event Type
    Malfunction
    Date Received
    December 21, 2016
    Report Date
    November 30, 2016
    Manufacturer
    DEXCOM INC.
    Product Code
    OYC
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME. (B)(6).

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE REPORTER CONTACTED ANIMAS, ALLEGING A CGM (DEX 007)) ISSUE. IT WAS REPORTED THAT THE TRANSMITTER OUT OF RANGE ALERT (CS 206) OCCURRED FOR MORE THAN THREE HOURS WHILE THE CGM WAS IN RANGE. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE MAY RESULT IN THE USER TO MISS THEIR BLOOD GLUCOSE (BG) TRENDING AND FAIL TO REACT TO ANY POTENTIAL BG EXCURSIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845386 ANIMAS VIBE OYC OYC DEXCOM INC.

    Patients

    Seq Age Sex Outcome Treatment
    1