BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXLAB X

    MDR report key: 25121569 · Received May 8, 2026

    Report

    Report Number
    3010825766-2026-00002
    Event Type
    Injury
    Date Received
    May 8, 2026
    Date of Event
    April 3, 2026
    Report Date
    May 8, 2026
    Manufacturer
    INPECO SA
    Product Code
    JQP
    UDI-DI
    07640172344002
    PMA / PMN Number
    K121012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DISTRIBUTOR CONFIRMED THAT THE THIRD PARTY ANALYZER (ADVIA HEMA) WAS PERFORMING WITHIN SPECIFICATIONS AND THAT NO MALFUNCTION OF THE INSTRUMENT WAS DETECTED. THE DISCREPANCY WAS ATTRIBUTED TO A CONFIGURATION ERROR WITHIN FLEXLAB X SOFTWARE DATA MANAGEMENT SYSTEM (DMS), WHICH TRANSMITS THE TEST ORDERS AND TEST RESULTS BETWEEN THE THIRD PARTY INSTRUMENTS AND LIS. IN DMS THE REQUEST/RESULT TRANSMISSION CODES FOR THE TWO TESTS HAD BEEN INCORRECTLY CONFIGURED. ACCORDING TO THE DISTRIBUTOR INVESTIGATION, THE ISSUE ORIGINATED FROM A MISTAKE MADE BY THEIR SERVICE PERSONNEL DURING THE DMS CONFIGURATION, ALTHOUGH NO DETAILED EXPLANATION OF THE SPECIFIC CONFIGURATION STEP INVOLVED WAS PROVIDED. THEY ALSO CLARIFIED THAT THE INPECO DOCUMENTATION USED DURING THE CONFIGURATION WAS CORRECT. THEREFORE, NO FURTHER ACTIONS FORESEEN.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED AN ISSUE INVOLVING THE REPORTING OF MONONUCLEAR (MN) AND POLYMORPHONUCLEAR (PMN) BODY FLUID CELL COUNTS WITHIN THE FLEXLAB X WORKFLOW. THE PROBLEM WAS IDENTIFIED ON (B)(6) 2026, WHEN THE LABORATORY NOTICED THAT MN AND PMN RESULTS DISPLAYED IN THE LABORATORY INFORMATION SYSTEM (LIS) DID NOT CORRESPOND TO THE VALUES DISPLAYED BY THE ANALYZER INTERFACE. ACCORDING TO THE INFORMATION PROVIDED, THE RESULTS FOR MONONUCLEAR CELLS WERE DISPLAYED AS POLYMORPHONUCLEAR IN THE LIS, AND VICE VERSA. ACCORDING TO THE INFORMATION SHARED BY THE DISTRIBUTOR, THE MISREPORTING OCCURRED BETWEEN (B)(6) 2026. DURING THIS PERIOD, 15 SAMPLES FROM 8 PATIENTS WERE AFFECTED. FOR ONE OF THEM, THE INVERTED MN/PMN VALUES CONTRIBUTED TO THE CONTINUATION OF UNNECESSARY ANTIBIOTIC THERAPY FOR APPROXIMATELY TWO ADDITIONAL DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619757 FLEXLAB X LABORATORY AUTOMATION SYSTEM JQP INPECO SA 07640172344002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other