BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INFINITY CORE SOFTWARE

    MDR report key: 9244901 · Received October 28, 2019

    Report

    Report Number
    1823260-2019-03872
    Event Type
    Malfunction
    Date Received
    October 28, 2019
    Date of Event
    October 3, 2019
    Report Date
    October 28, 2019
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JQP
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). THE INVESTIGATION CONFIRMED THAT THE "ALTERNATE" OPERATION IS NOT PROPERLY HANDLING THE HOST MESSAGES RECEIVED WHEN THE FIELDS INVOLVED IN THE OPERATION ARE THE "VALUERESULT" TYPE AND THE FIELDS ARE PLACED IN DIFFERENT STRIPS. THE INVESTIGATION CONFIRMED THIS AS A SOFTWARE ISSUE, AS THE SOFTWARE SHOULD PERFORM THE "ALTERNATE" OPERATION CORRECTLY REGARDLESS OF THE TYPE OF FIELDS INVOLVED AND THE STRIPS WHERE THEY ARE PLACED. A WORKAROUND HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    THE INITIAL REPORTER COMPLAINED OF AN ISSUE WITH COBAS INFINITY CORE LICENSE SOFTWARE VERSION (B)(6). AT THE HOST MESSAGE CONFIGURATION SCREEN, THE USER CAN CONFIGURE AND DEFINE THE DATA TO BE CAPTURED IN INCOMING MESSAGES FROM THE HOSTS. WHEN DEFINING THE MESSAGE FIELDS THE USER MUST SELECT THE OPERATION RELATED TO THAT FIELD. ONE OPTION IS "ALTERNATE" WHICH ALLOWS REPLACING AN EMPTY FIELD WITH THE FIELD FOLLOWING IT ACCORDING TO THE ORDER SET IN THE ORDER FIELD. THE CUSTOMER ALLEGES THAT THEY HAVE CONFIGURED THE "ALTERNATE" OPERATION BETWEEN 2 FIELDS FROM DIFFERENT STRIPS OF THE MESSAGES: "TEST RESULT" FIELD AND THE "COMMENTS" FIELD. THE MESSAGE RECEIVED BY THE HOST HAS A VALUE IN THE "TEST RESULT" FIELD; HOWEVER, THE "ALTERNATE" OPERATION IS PROCESSING THE MESSAGE AS AN EMPTY FIELD AND SAVING THE TEST RESULT IN THE "COMMENTS" FIELD CAUSING THE ACTUAL TEST RESULT VALUE TO APPEAR AS IT IS MISSING. THE FOLLOWING IS AN EXAMPLE OF THIS BEHAVIOR: THE STRIP OBX, REFERRED TO THE TEST INFORMATION, WHICH CONTAINS THE "TEST RESULT" VALUE ("VALUERESULT" FIELD) WITH THE ORDER 1 FOR THE "ALTERNATE" OPERATION. THE STRIP NTE, REFERRED TO THE COMMENTS WHICH CONTAINS TEST "COMMENTS" ("VALUERESULT" FIELD) WITH THE ORDER 2 FOR THE "ALTERNATE" OPERATION. THE INVESTIGATION CONFIRMED THAT THE INFINITY SOFTWARE IS NOT SAVING THE "TEST RESULT" VALUE IN THIS SITUATION BUT WILL SAVE THE TEST "COMMENTS" INSTEAD. THIS ISSUE COULD IMPACT THE INTERPRETATION OF PATIENT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1040906 COBAS INFINITY CORE SOFTWARE CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE JQP ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1