BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 5381023 · Received January 20, 2016

    Report

    Report Number
    2531779-2016-02119
    Event Type
    Malfunction
    Date Received
    January 20, 2016
    Report Date
    January 5, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 01/05/2016 WITH THE FOLLOWING FINDINGS: INVESTIGATION REVEALED THAT THE DISPLAY WAS DIM, FADING, AND DISCOLORED. UNRELATED TO THE DISPLAY ISSUE, INVESTIGATION REVEALED THAT THE AUDIO BOLUS BUTTON COVER WAS DETACHED. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED CONTAMINATION THAT THE DISPLAY WAS DIM, FADING, AND DISCOLORED. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 01/05/2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38273 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1