BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTRUMENT MANAGER SOFTWARE

    MDR report key: 21777830 · Received April 4, 2025

    Report

    Report Number
    1225673-2025-00001
    Event Type
    Malfunction
    Date Received
    April 4, 2025
    Date of Event
    March 6, 2025
    Report Date
    April 4, 2025
    Manufacturer
    DATA INNOVATIONS LLC
    Product Code
    JQP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A COLLABORATIVE INVESTIGATION WAS COMPLETED BY DATA INNOVATIONS LLC (MANUFACTURER) AND THE USER FACILITY. INVESTIGATION DETERMINED THAT TWO RULES (USER FACILITY PROGRAMMED LOGIC) IN INSTRUMENT MANAGER DID NOT FIRE AS EXPECTED FOR A SINGLE SPECIMEN. ONE RULE IS INTENDED TO CHANGE A NUMERICAL INTERPRETED RESULT VALUE FROM QUANTITATIVE TO QUALITATIVE AND THE SECOND RULE IS INTENDED TO SUPPRESS COMMENTS (E.G. REMOVE TEST AND SPECIMEN COMMENTS SO THEY ARE NOT SENT TO THE LIS WITH THE RESULT). WHEN THE RESULT CAME INTO THE LABORATORY INFORMATION SYSTEM (LIS), THE RESULT WAS A NUMERIC VALUE WHEN IT SHOULD HAVE BEEN A VALUE OF DETECTED OR NOT DETECTED, AND THE TEST RESULT RELEASED TO THE PATIENT CHART WAS A BLANK VALUE. THE TEST RESULTS WERE THEN VERBALLY READ TO THE PROVIDER. THE RESULT MESSAGE WAS RESENT AGAIN FROM THE LABORATORY INSTRUMENT TO THE LABORATORY INFORMATION SYSTEM (LIS) AND THE RULES FIRED AS EXPECTED. THERE WAS NO PATIENT HARM AS A RESULT OF THIS INCIDENT. DATA INNOVATIONS HAS BEEN UNABLE TO RECREATE THE ISSUE AND THEREFORE HAS NOT YET DETERMINED IF THIS WAS A MALFUNCTION OF INSTRUMENT MANAGER SOFTWARE.

    Description of Event or Problem · 0

    A FACILITY REPORTED ON 06 MARCH 2025 THAT FOR A FLU/COVID/RSV TEST PANEL, TWO RULES (USER FACILITY PROGRAMMED LOGIC) INTENDED TO CHANGE INTERPRETED RESULT VALUES FROM QUANTITATIVE (E.G. NUMERICAL VALUE) TO QUALITATIVE VALUE (E.G. DETECTED/NOT DETECTED) AND TO REMOVE CERTAIN COMMENTS FROM BEING REPORTED WITH THE RESULT DID NOT FIRE AS EXPECTED FOR A SINGLE SPECIMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716464 INSTRUMENT MANAGER SOFTWARE CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE JQP DATA INNOVATIONS LLC 8.17.20

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown