BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 6099125 · Received November 14, 2016

    Report

    Report Number
    2531779-2016-31273
    Event Type
    Malfunction
    Date Received
    November 14, 2016
    Report Date
    October 19, 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 012) ISSUE. IT WAS REPORTED THAT THE CONTINUOUS GLUCOSE MONITORING (CGM) READINGS WERE INACCURATE WHEN COMPARED TO THE FINGER STICK BLOOD GLUCOSE (BG) VALUES. THERE WAS NO INDICATION THAT THE DEVICE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE MAY RESULT IN THE USER REACTING TO INCORRECT CONTINUOUS GLUCOSE MONITORING DATA WHICH MAY LEAD TO BG EXCURSIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749759 ANIMAS VIBE OYC OYC DEXCOM INC.

    Patients

    Seq Age Sex Outcome Treatment
    1