BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 7001248 · Received November 3, 2017

    Report

    Report Number
    2531779-2017-25745
    Event Type
    Malfunction
    Date Received
    November 3, 2017
    Report Date
    October 12, 2017
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    OYC
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CONTRACT MANUFACTURER: DEXCOM INC. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS, ALLEGING A THE CONTINUOUS GLUCOSE MONITORING (CGM) READINGS WERE INACCURATE AS 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
    779234 ANIMAS VIBE INSULIN INFUSION PUMP OYC ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR