BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 8395543 · Received March 6, 2019

    Report

    Report Number
    2531779-2019-01716
    Event Type
    Malfunction
    Date Received
    March 6, 2019
    Report Date
    March 5, 2019
    Manufacturer
    ANIMAS LLC
    Product Code
    OYC
    UDI-DI
    10840406103199
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    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 03/05/2019 WITH THE FOLLOWING FINDINGS: DEVICE EVALUATION: ON INVESTIGATION, THE BATTERY COMPARTMENT WAS NOTED TO BE CRACKED.

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A CASE/CONDITION ISSUE. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 03/05/2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189088 ANIMAS VIBE INSULIN INFUSION PUMP OYC ANIMAS LLC 10840406103199

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR