BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3062732 · Received April 17, 2013

    Report

    Report Number
    2531779-2013-04391
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Report Date
    March 20, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). SUBMITTED: 04/16/2013 DEVICE EVALUATION: THE INSULIN PUMP HAS BEEN RETURNED AND ADDITIONAL INVESTIGATION WAS PERFORMED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: ON INVESTIGATION, THE PUMP POWERED ON PROPERLY AND THE DISPLAY SCREEN BECAME FULLY ILLUMINATED. A VERTICAL COLOR SPECTRUM LINE WAS OBSERVED ON THE RIGHT SIDE OF THE DISPLAY SCREEN. THE PUMP WAS OPENED AND REVEALED THE DISPLAY WAS NOT POSITIONED PROPERLY AND WAS CROOKED.

    Description of Event or Problem · 1

    THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(4) 2013: DURING INVESTIGATION, THE DISPLAY SCREEN WAS NOTED TO BE CROOKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165189 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR