BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXLAB

    MDR report key: 22961997 · Received September 4, 2025

    Report

    Report Number
    3010825766-2025-00006
    Event Type
    Malfunction
    Date Received
    September 4, 2025
    Date of Event
    August 8, 2025
    Report Date
    October 28, 2025
    Manufacturer
    INPECO SA
    Product Code
    JQP
    UDI-DI
    07640172340004
    PMA / PMN Number
    K121012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE MISMATCH STARTS AFTER ERRORS WHICH REQUIRE TO OPEN THE ALIQUOTER MODULE PRINTER HEAD IF THE OPERATORS LEAVE SAMPLE TUBES INSIDE THE PRINTER. THE INVESTIGATION IS ONGOING TO DETERMINE THE SPECIFIC SCENARIOS WHICH MAY REQUIRE THE OPENING OF THE PRINTER HEAD TRIGGERING THE ISSUE AND TO IDENTIFY HOW TO FIX IT.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION HAS CONFIRMED THAT THE ALIQUOTER MODULE X (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 ALIQUOTER MODULE X (MALX) AND DO NOT EMPTY THE PRINTER TUBES BUFFER REMOVING ALL THE SECONDARY SAMPLE TUBES. THE ISSUE MAY IMPACT THE INVOLVED PATIENTS ONLY IF THE SECONDARY SAMPLE TUBES AFFECTED BY THE ISSUE ARE ROUTED TO AN OUTPUT MODULE AND THEY ARE UNLOADED FROM THE AUTOMATION SYSTEM. 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 ANOTHER OCCURRENCE OF THE EVENT DESCRIBED IN MDR 3010825766-2025-00003 IN THE SAME LABORATORY. THE ALIQUOTER MODULE (ALX, #3) CAUSED THE MISMATCH OF MORE THAN 200 TUBES BETWEEN DAUGHTER AND MOTHER TUBES. THE IMPACTED SAMPLE TUBES HAD TO BE MANUALLY RETRIEVED BY THE OPERATORS. THE MISMATCH PROBABLY STARTED AFTER THE ERROR "M34E0 - TUBE LABELED ORIENTATION VERIFICATION ACTIVATED ERROR" AT AROUND 5:11AM IN THE NIGHT OF THE (B)(6) 2025. ACCORDING TO THE LABORATORY WORKFLOW, THE MOTHER TUBES ARE TESTED BEFORE BEING SENT TO THE ALIQUOTER MODULE. THE ALIQUOT SAMPLE TUBES CAN BE SORTED AT THE INPUT OUTPUT MODULE (IOX) TO PERFORM PCR TESTS OUTSIDE THE AUTOMATION SYSTEM OR SENT TO THE TESTED ON THE COBAS 8000 INSTRUMENT. IN THE FIRST CASE, THE OPERATOR MAY BECOME AWARE OF THE MISMATCH WHEN HE FINDS IN THE SORTING RACK EITHER A SAMPLE TUBE WITH A TEST NAME PRINTED ON THE LABEL DIFFERENT FROM THE TEST NAME WRITTEN ON THE IOX DISPLAY BAR OR A SAMPLE TUBE WITH AN UNEXPECTED SID. IF THE MISMATCH IS NOT NOTICED, THE EVENT MAY LEAD TO INCORRECT RESULTS. THE CUSTOMER DID NOT COMMUNICATE ANY REAL CLINICAL IMPACT ON THE INVOLVED PATIENTS. IN THE SECOND CASE, DUE TO THE ANALYZER'S PICK-AND-PLACE MECHANISM, THESE SAMPLE TUBES ARE SCANNED BY A BARCODE READER BEFORE BEING UNLOADED FROM THE TRACK. THE AUTOMATION SYSTEM FLAGGED WITH THE ERROR 5D22 - SAMPLE ID MISMATCH THE INVOLVED TUBES AND SENT THEM TO THE ERROR LANE OF THE IOX TO BE MANUALLY MANAGED BY THE OPERATORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2233741 FLEXLAB LABORATORY AUTOMATION SYSTEM JQP INPECO SA 07640172340004

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown