BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 4455107 · Received January 27, 2015

    Report

    Report Number
    2531779-2015-03167
    Event Type
    Malfunction
    Date Received
    January 27, 2015
    Report Date
    January 19, 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

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 01/19/2015 WITH THE FOLLOWING FINDINGS: DURING TESTING, THE PUMP POWERED ON WITH A PINK COLORED CONTRAST. INITIAL REPORTER: (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED TO ANIMAS. PRODUCT ANALYSIS EVALUATED THE PUMP AND FOUND THAT THE PUMP DISPLAY SCREEN WAS DISCOLORED. THIS REPORT IS MADE BASED ON THE RESULTS OF EVALUATION COMPLETED 01/19/2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62133 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1