BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3883299 · Received June 19, 2014

    Report

    Report Number
    2531779-2014-17595
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Report Date
    June 16, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/16/2014 WITH THE FOLLOWING FINDINGS: THE PUMP EZPRIME SEQUENCE WAS COMPLETED SUCCESSFULLY AND THE PUMP WAS EXERCISED FOR 24 HOURS WITHOUT ANY ISSUES. A FORCE SENSOR CALIBRATION TEST WAS PERFORMED DURING TESTING AND THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION. THE PUMP WAS OPENED AND NO CONTAMINATION WAS FOUND IN THE FORCE SENSOR ASSEMBLY. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED TO ANIMAS. PRODUCT ANALYSIS EVALUATED THE PUMP AND FOUND THAT THE FORCE SENSOR WAS OUT OF CALIBRATION. THIS REPORT IS MADE BASED ON THE RESULTS OF EVALUATION COMPLETED ON 06/16/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360598 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR