BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXLAB X

    MDR report key: 23523280 · Received November 11, 2025

    Report

    Report Number
    3010825766-2025-00007
    Event Type
    Malfunction
    Date Received
    November 11, 2025
    Date of Event
    October 23, 2025
    Report Date
    November 11, 2025
    Manufacturer
    INPECO SA
    Product Code
    JQP
    UDI-DI
    07640172344002
    PMA / PMN Number
    K121012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    THE ISSUE HAS BEEN FIXED IN MALX INCREMENT 1.4. INPECO HAS SUBMITTED A MANDATORY CORRECTIVE ACTION RELATED TO THIS ISSUE (REFERENCE CODE: 3010825766 - 102725 - 002 - C).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED AN OCCURRENCE OF AN ALREADY KNOWN ISSUE OF THE ALIQUOTER MODULE X (MALX). THE MALX MAY GENERATE SECONDARY SAMPLE TUBES WITHOUT LABELS OR WITH A LABEL REPORTING INFORMATION INCONSISTENT WITH THE ACTUAL SAMPLE DISPENSED INTO THE TUBE. THE EVENT OCCURS IF THE OPERATORS OPEN THE PRINTER HEAD OF THE MALX AND DO NOT EMPTY THE PRINTER TUBES BUFFER REMOVING ALL THE SECONDARY SAMPLE TUBES. IN THIS CASE THE OPERATOR WAS RECOVERING THE ERROR M34CC "TUBE HOPPER MOVE TO UP POSITION FAILURE" WHICH DID NOT ACTUALLY REQUIRE TO OPEN THE PRINTER HEAD. IN THIS LABORATORY THE SECONDARY TUBES ARE SORTED INTO AN INPUT OUTPUT MODULE (IOX) OUTPUT RACK. FOR THE SECONDARY SAMPLE TUBE WITH THE WRONG INFORMATION PRINTED ON THE LABEL, IF THE RACK IS UNLOCKED FROM THE LANE AND THE TUBE IS RE-LOADED ON THE AUTOMATION SYSTEM OR IS TESTED OFF TRACK, THE MISMATCH BETWEEN THE LABEL INFORMATION AND ACTUAL SAMPLE CANNOT BE DETECTED AND THE EVENT MAY LEAD TO INCORRECT RESULTS. THE OPERATOR MAY BECOME AWARE OF THE MISMATCH WHEN THE IMPACTED SECONDARY TUBE IS UNLOADED IN A POSITION OF THE IOX RACK THAT DOESN'T MATCH THE ONE DISPLAYED ON THE USER GRAPHIC INTERFACE. FOR THE SECONDARY SAMPLE TUBE WITHOUT LABEL THE TRACEABILITY IS LOST WHEN THE SAMPLE TUBE IS UNLOADED FROM THE CARRIER. THE EVENT MAY CAUSE DELAYED TEST RESULTS IN CASE OF TESTS TO BE EXECUTED OFF TRACK. ACCORDING TO THE INFORMATION PROVIDED BY THE DISTRIBUTOR THE CUSTOMER HAS DETECTED DISCORDANT RESULT IN SEVERAL SECONDARY SAMPLES. NO REAL CLINICAL IMPACTS ON THE INVOLVED PATIENTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1901959 FLEXLAB X LABORATORY AUTOMATION SYSTEM JQP INPECO SA 07640172344002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown