BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 4905236 · Received July 10, 2015

    Report

    Report Number
    2531779-2015-23114
    Event Type
    Malfunction
    Date Received
    July 10, 2015
    Report Date
    June 22, 2015
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2015 WITH THE FOLLOWING FINDINGS: INVESTIGATION REVEALED THAT THE DISPLAY SCREEN WAS DISCOLORED. UNRELATED TO THE DISPLAY ISSUE, INVESTIGATION REVEALED THAT THE AUDIO BOLUS BUTTON COVER AND THE KEYPAD COVER WERE BOTH TORN; ALL BUTTONS RESPONDED NORMALLY TO BUTTON PRESSES. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THAT THE DISPLAY SCREEN WAS DISCOLORED. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(4) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449006 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1