BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 8540201 · Received April 23, 2019

    Report

    Report Number
    2531779-2019-02746
    Event Type
    Malfunction
    Date Received
    April 23, 2019
    Report Date
    April 22, 2019
    Manufacturer
    ANIMAS LLC
    Product Code
    OYC
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 04/22/2019 WITH THE FOLLOWING FINDINGS: DEVICE EVALUATION: ON INVESTIGATION, THE DISPLAY SCREEN WAS FOUND TO BE CRACKED AND WAS BLANK WHEN THE PUMP WAS POWERED ON. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A DISPLAY ISSUE. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 04/22/2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334136 ANIMAS VIBE INSULIN INFUSION PUMP OYC ANIMAS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR