BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 5298141 · Received December 15, 2015

    Report

    Report Number
    2531779-2015-45385
    Event Type
    Malfunction
    Date Received
    December 15, 2015
    Report Date
    December 3, 2015
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 12/03/2015 WITH THE FOLLOWING FINDINGS: DURING TESTING, THE DISPLAY WAS FOUND TO BE DIM AND DISCOLORED. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A DISPLAY ISSUE. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 12/03/2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826800 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1