BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3738247 · Received April 10, 2014

    Report

    Report Number
    2531779-2014-09540
    Event Type
    Malfunction
    Date Received
    April 10, 2014
    Report Date
    March 24, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    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 03/24/2014 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE DISPLAY SCREEN WAS DIM AND DISCOLORED. UNRELATED TO THE DISPLAY ISSUE, THE PAINT FINISH ON THE PUMP WAS FADED, CHIPPED, AND WEARING OFF. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A DISPLAY FAILURE. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 03/24/2014. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217998 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1