BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 6915661 · Received October 5, 2017

    Report

    Report Number
    2531779-2017-23065
    Event Type
    Malfunction
    Date Received
    October 5, 2017
    Report Date
    September 15, 2017
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    OYC
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RETURN IS NOT REQUIRED. CONTRACT MANUFACTURER: DEXCOM INC. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS ALLEGING A CGM (DEX 076) ISSUE. IT WAS ALLEGED THAT THE SENSOR WIRE WAS MISSING/DETACHED WHEN THE SENSOR WAS REMOVED FROM THE SKIN. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE A DEVICE COMPONENT IS MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694691 ANIMAS VIBE INSULIN INFUSION PUMP OYC ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR