BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 8217089 · Received January 4, 2019

    Report

    Report Number
    2531779-2019-00091
    Event Type
    Malfunction
    Date Received
    January 4, 2019
    Report Date
    January 2, 2019
    Manufacturer
    ANIMAS LLC
    Product Code
    OYC
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED ISSUE. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 01/02/2019. THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 01/02/2019 WITH THE FOLLOWING FINDINGS: DEVICE EVALUATION: THE DISPLAY WAS NOTED TO BE DIM/FADED/DISCOLORED.

    Description of Event or Problem · 1

    THE INSULIN PUMP WAS RETURNED TO THE MANUFACTURER AND INVESTIGATION OF THE DEVICE WAS COMPLETED 01/02/2019. ON INVESTIGATION, THE DISPLAY SCREEN WAS NOTED TO BE DIM/FADED/DISCOLORED. THIS COMPLAINT IS BEING REPORTED AS A RESULT OF PRODUCT FAILURE FOUND DURING INVESTIGATION AND NOT PREVIOUSLY ALLEGED OR REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11488 ANIMAS VIBE INSULIN INFUSION PUMP OYC ANIMAS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1