BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 11829042 · Received May 14, 2021

    Report

    Report Number
    1225673-2021-00009
    Event Type
    Malfunction
    Date Received
    May 14, 2021
    Date of Event
    April 15, 2021
    Report Date
    May 14, 2021
    Manufacturer
    DATA INNOVATIONS LLC
    Product Code
    JQP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DRIVERS ARE AN ACCESSORY COMPONENT OF THE INSTRUMENT MANAGER SYSTEM WHICH ENABLE COMMUNICATION WITH LABORATORY INSTRUMENTS. INVESTIGATION OF THIS INCIDENT HAS BEEN DETERMINED TO BE AN ACCESSORY DRIVER MALFUNCTION. ON (B)(6) 2021, DATA INNOVATIONS LABORATORY SOLUTION CONSULTANT WORKING WITH A CUSTOMER USING THE ABBOTT DIAGNOSTICS ALINITY CI-SERIES INSTRUMENT USING THE INSTRUMENT MANAGER ABBOTT ALINITY CI-SERIES ACCESSORY DRIVER (ABDICQII) V8.00.0005, FOUND THAT DURING INSTALLATION SERVICE, THE ABBOTT DIAGNOSTICS ALINITY CI-SERIES INSTRUMENT WAS CONFIGURED TO PERFORM AUTO-DILUTIONS AND COLLATE RESULTS. WITH THIS CONFIGURATION, THE INSTRUMENT WILL TRANSMIT BOTH RESULTS IN A SINGLE MESSAGE. WHEN THE INSTRUMENT MANAGER ABBOTT ALINITY ACCESSORY DRIVER PARSES THE RESULTS, IT WILL ASSIGN THE FIRST DILUTION RECEIVED TO BOTH OF THE RESULTS AND FLAGS BOTH RESULTS AS 'RERUN = YES'. THE DATA INNOVATIONS LABORATORY SOLUTION CONSULTANT RECOGNIZED THIS TO BE AN UNUSUAL OUTPUT FOR THE ABBOTT DIAGNOSTICS ALINITY CI-SERIES INSTRUMENT AND ADVISED THE CUSTOMER TO WORK WITH ABBOTT DIAGNOSTICS FOR SUPPORT. THE ABBOTT DIAGNOSTICS FIELD ENGINEER CHANGED A SETTING ON THE ABBOTT DIAGNOSTICS ALINITY CI-SERIES INSTRUMENT FROM 'COLLATED TRANSMISSION' TO 'SINGLE RESULT TRANSMISSION'. THIS RESULTS IN THE INSTRUMENT SENDING EACH DILUTION SEPARATELY TO PREVENT RECURRENCE OF THE ISSUE. INVESTIGATION OF THE ISSUE DETERMINED THIS TO BE A MALFUNCTION OF THE ABBOTT ALINITY CI-SERIES ACCESSORY DRIVER (ABDICQII), IDENTIFIED IN DATA INNOVATIONS KNOWN ISSUE (B)(4). THE INVESTIGATION ALSO DETERMINED NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723418 ACCESSORY OF INSTRUMENT MANAGER - ABBOTT ALINITY CI-SERIES DRIVER (ABDICQII) CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE JQP DATA INNOVATIONS LLC ABDICQII V8.00.0005

    Patients

    Seq Age Sex Outcome Treatment
    1