BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 8380655 · Received February 28, 2019

    Report

    Report Number
    2531779-2019-01616
    Event Type
    Malfunction
    Date Received
    February 28, 2019
    Report Date
    February 25, 2019
    Manufacturer
    ANIMAS LLC
    Product Code
    OYC
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 25-FEB-2019. WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED CONTAMINATION UNDER ALL OF THE KEYPAD BUTTONS. THE KEYPAD COVER WAS FOUND TO BE PEELING FROM THE BASE. 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. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. EVALUATION REVEALED CONTAMINATION UNDER ALL OF THE KEYPAD BUTTONS. THE KEYPAD COVER WAS FOUND TO BE PEELING FROM THE BASE. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 25-FEB-2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170414 ANIMAS VIBE INSULIN INFUSION PUMP OYC ANIMAS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR