BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 8252198 · Received January 16, 2019

    Report

    Report Number
    2531779-2019-00448
    Event Type
    Malfunction
    Date Received
    January 16, 2019
    Report Date
    January 9, 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 HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 01/09/2019 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE AUDIO BOLUS BUTTON COVER WAS LIFTED. THE AUDIO BOLUS BUTTON WAS INOPERABLE DUE TO THE AUDIO BOLUS BUTTON SLUG MISSING. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THE AUDIO BOLUS BUTTON WAS INOPERABLE. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 01/09/2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47285 ANIMAS VIBE INSULIN INFUSION PUMP OYC ANIMAS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1