BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INFINITY CORE SOFTWARE

    MDR report key: 17475530 · Received August 7, 2023

    Report

    Report Number
    1823260-2023-02538
    Event Type
    Malfunction
    Date Received
    August 7, 2023
    Date of Event
    July 11, 2023
    Report Date
    August 29, 2023
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JQP
    PMA / PMN Number
    EXEMPTNA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION HAS IDENTIFIED TWO ISSUES WITH THE SOFTWARE. PRODUCT LABELING FOR COBAS INFINITY STATES THAT AN "OCE" ALARM IS FLAGGED ON A RESULT WHEN THE OPERATOR PERFORMING THE MEASUREMENT HAS SELECTED AN ERROR COMMENT. IN THIS CASE, THE SYSTEM HAS BEEN CONFIGURED WITH A COMMENT CALLED 'PATIENT VERWECHSELT' WITH THE OPTION 'MARK AS ERRONEOUS (OPTIONAL)' ACTIVATED IN THE 'CONFIGURATION > DEVICES > COMMENT ASSIGNMENT¿ SCREEN. DURING THE INVESTIGATION, IT COULD BE SEEN THAT THE COMMENT RECEIVED IN THE APPLICATION CONTAINED THE ¿C1:¿ PREFIX, DISPLAYING THE COMMENT ¿C1:PATIENT VERWECHSELT¿. AS THIS COMMENT HAS THE PREFIX ¿C1:¿, THE APPLICATION DOES NOT MATCH THE RECEIVED COMMENT WITH THE ONE CONFIGURED IN THE APPLICATION AND CONSEQUENTLY, THE ASSOCIATED RESULT IS NOT MARKED WITH THE ¿OCE¿ ALARM AND IT IS VALIDATED AUTOMATICALLY. FOR THE FIRST SOFTWARE ISSUE IDENTIFIED, THE ¿C1:¿ PREFIX IS NOT BEING REMOVED BY THE DRIVER WHICH CAUSES THE APPLICATION NOT TO MATCH THE COMMENT RECEIVED BY THE INSTRUMENT WITH THE ONE CONFIGURED IN THE APPLICATION. FOR THE SECOND IDENTIFIED SOFTWARE ISSUE, THE APPLICATION IS NOT TRIGGERING THE ¿OCE¿ ALARM WHEN IT IS SENT AS AN ¿ORDER¿ COMMENT. THERE IS NO PATIENT RISK SINCE PRODUCT LABELING HAS REPEATED WARNINGS ABOUT THE NEED FOR TESTING WHEN CONFIGURING THE DRIVERS AND THEIR WORKFLOW BEFORE GOING INTO PRODUCTION.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY HAD AN ISSUE WITH THE COBAS INFINITY SOFTWARE. WHEN A RESULT COMING FROM AN INSTRUMENT IS MARKED OR FLAGGED AS PROBLEMATIC OR ERRONEOUS, THE COBAS INFINITY SOFTWARE IS ALLOWING THE RESULT TO BE AUTO-VALIDATED AND RELEASED OUTSIDE OF THE LABORATORY. IT IS EXPECTED FOR THE COBAS INFINITY TO HOLD THESE VALUES AS PENDING VALUES AND NOT TO RELEASE THESE OUTSIDE OF THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324740 COBAS INFINITY CORE SOFTWARE CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE JQP ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown