BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 6943172 · Received October 11, 2017

    Report

    Report Number
    2531779-2017-23595
    Event Type
    Malfunction
    Date Received
    October 11, 2017
    Report Date
    September 18, 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

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

    Description of Event or Problem · 1

    BG METER READ 105MG/DL, AND CGM READ 55 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719239 ANIMAS VIBE INSULIN INFUSION PUMP OYC ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR