BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 8309962 · Received February 6, 2019

    Report

    Report Number
    2531779-2019-00921
    Event Type
    Malfunction
    Date Received
    February 6, 2019
    Report Date
    February 1, 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

    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 01-FEB-2019 WITH THE FOLLOWING FINDINGS: DEVICE EVALUATION: ON INVESTIGATION, THE BATTERY COMPARTMENT WAS NOTED TO BE CRACKED, THE DISPLAY WAS NOTED TO BE DIM/FADED/DISCOLORED AND CONTAMINATION WAS FOUND UNDER THE CONTACTS OF ALL THE KEYPAD BUTTONS. (B)(4).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A CASE/CONDITION ISSUE, A KEYPAD ISSUE, AND A DISPLAY ISSUE. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 01-FEB-2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106070 ANIMAS VIBE INSULIN INFUSION PUMP OYC ANIMAS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1