BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 6873408 · Received September 18, 2017

    Report

    Report Number
    2531779-2017-21533
    Event Type
    Malfunction
    Date Received
    September 18, 2017
    Report Date
    August 21, 2017
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    OYC
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 8/21/2017 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE DISPLAY WAS DIM AND DISCOLORED. ANIMAS CORPORATION (B)(4).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A BATTERY COMPARTMENT CRACK. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 8/21/2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652389 ANIMAS VIBE INSULIN INFUSION PUMP OYC ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR