BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESSORY TO INSTRUMENT MANAGER - ABBOTT ALINITY CI-SERIES DRIVER (ABDICQII)

    MDR report key: 11739004 · Received April 28, 2021

    Report

    Report Number
    1225673-2021-00007
    Event Type
    Malfunction
    Date Received
    April 28, 2021
    Date of Event
    March 30, 2021
    Report Date
    April 28, 2021
    Manufacturer
    DATA INNOVATIONS LLC
    Product Code
    JQP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636253 ACCESSORY TO INSTRUMENT MANAGER - ABBOTT ALINITY CI-SERIES DRIVER (ABDICQII) CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE JQP DATA INNOVATIONS LLC ABDICQII V8.00.0004 AND V8.00.0005

    Patients

    Seq Age Sex Outcome Treatment
    1