BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXLAB

    MDR report key: 17496681 · Received August 10, 2023

    Report

    Report Number
    3010825766-2023-00007
    Event Type
    Malfunction
    Date Received
    August 10, 2023
    Date of Event
    July 17, 2023
    Report Date
    November 10, 2023
    Manufacturer
    INPECO SA
    Product Code
    CEM
    PMA / PMN Number
    K121012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE INITIAL REPORT (MDR 3010825766-2023-00007) WAS SUBMITTED ON AUGUST 10TH, 2023 ADDITIONAL INFORMATION: THE INVESTIGATION CONFIRMED THAT THE COBAS 8000 INTERFACE MODULE FIRMWARE MAY COMMUNICATE TO THE AUTOMATION SOFTWARE THAT THE SAMPLE TUBE HAS BEEN PLACED IN A RACK OF ANALYZER TO BE SAMPLED WHEN THE SAMPLE TUBE HAS BEEN ALREADY SAMPLED AND RELEASED ON THE AUTOMATION TRACK. FOR THIS REASON, THE LAST SAMPLE TUBE LOCATION DISPLAYED ON THE AUTOMATION SOFTWARE USER INTERFACE (IUI) IS WRONG AND MISLEADING. DEPENDING ON THE REAL POSITION OF THE SAMPLE TUBE WHEN THE SAMPLE LOCATION NOTIFICATION IS RECEIVED, THE ISSUE MAY LEAD TO DELAY OF TESTS RESULTS IF THERE ARE STILL TEST ORDERS TO BE PERFORMED ON THE SAMPLE TUBE. THE ISSUE IS CAUSED BY A FIRMWARE BUG PRESENT ONLY IN SPECIFIC FIRMWARE VERSIONS OF THE COBAS 8000 INTERFACE MODULE (COBASA_2.2.0 AND COBASA_2.3.0). THE BUG WILL BE FIXED IN THE NEXT FIRMWARE VERSION. INSPECTOR HAS SUBMITTED A MANDATORY CORRECTIVE ACTION RELATED TO THIS ISSUE (REFERENCE CODE: 3010825766 - 110623 - 002 - C).

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING. BASED ON THE CURRENT FINDINGS, THE FIRMWARE OF THE INPECO INTERFACE MODULE WITH COBAS 8000 PRODUCED THE SAMPLE LOCATION NOTIFICATION (EXPECTED WHEN THE TUBES WERE PLACED IN A RACK OF THE ANALYZER) AFTER THE TUBES RETURNED ON THE TRACK AND WERE STORED IN THE SRM. THE AUTOMATION SOFTWARE UPDATED THE SAMPLE POSITION FROM THE SRM TO THE COBAS 8000, SO THE AUTOMATIC RETRIEVE OF THE SAMPLE FROM THE SRM WASN'T PERFORMED. THE TEST ORDERS WERE DISPLAYED ON SOFTWARE USER INTERFACE AS STILL TO BE EXECUTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED 3 CASES OF DELAYED TEST RESULTS ON COBAS 8000 CONNECTED TO THE FLEXLAB AUTOMATION SYSTEM. THE INVOLVED SAMPLE TUBES WERE LOADED ON THE FLEXLAB, TESTED ON COBAS 8000, STORED IN THE STORAGE AND RETRIEVAL MODULE (SRM) WHEN AN AUTOMATIC RERUN REQUEST WAS RECEIVED. THE RERUN TESTS WERE NOT EXECUTED SINCE THE AUTOMATION SOFTWARE HAD THE WRONG SAMPLE TUBES LOCATION. NO IMPACTS ON THE INVOLVED PATIENTS HAVE BEEN REPORTED SINCE THE OPERATORS WERE ABLE TO NOTICE THAT THE SAMPLE TUBES REMAINED IN INCOMPLETE STATUS (THE ADDITIONAL TEST ORDERS WERE NOT EXECUTED) AND THEY OBTAINED NEW SAMPLE TUBES TO COMPLETE THE TESTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797532 FLEXLAB LABORATORY AUTOMATION SYSTEM CEM INPECO SA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown