BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSMEX PS-10

    MDR report key: 21111764 · Received January 9, 2025

    Report

    Report Number
    1000515253-2025-00001
    Event Type
    Malfunction
    Date Received
    January 9, 2025
    Date of Event
    December 12, 2024
    Report Date
    January 9, 2025
    Manufacturer
    SYSMEX CORPORATION
    Product Code
    PER
    UDI-DI
    04987562501908
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON 12.06.2024, SYSMEX EUROPE (SEU) BECAME AWARE OF A SOFTWARE ISSUE INVOLVING SAMPLE PREPARATION SYSTEM PS-10 SOFTWARE VERSION 1.6. PER SYSMEX EUROPE, A SYSMEX FIELD SERVICE REPRESENTATIVE (FSR) IN FRANCE HAD REPORTED THAT ANTIBODY (AB) PIPETTING SCRIPTS WERE FOUND TO MISS THE PROBE WASHING SUBROUTINE EXECUTION AT A CUSTOMER SITE. THE ISSUE WAS IDENTIFIED WHEN TROUBLESHOOTING A CUSTOMER REPORT OF GENERATION OF FALSE POSITIVE CELL POPULATIONS IN SOME SAMPLES ANALYZED ON A FLOWCYTOMETRY DEVICE. NO WARNING WAS ISSUED BY THE DEVICE TO ALERT THE OPERATOR OF THE MISSED WASH SEQUENCE. ON 12.09.2024, THE DEVICE LOGFILES WERE RECEIVED BY SEU AND SEU WAS ABLE TO REPRODUCE THE ERROR ON AN IN-HOUSE DEVICE OPERATING WITH SOFTWARE VERSION 1.6. SEU ESCALATED THE CASE TO THE CONTRACT MANUFACTURER FOR THE PS-10. ON 12.12.2024, IT WAS CONFIRMED THAT THE ISSUE WAS CAUSED BY A SOFTWARE DEFECT THAT HAD BEEN INTRODUCED WITH SOFTWARE VERSION 1.5 AND ALSO MANIFESTED IN SOFTWARE VERSION 1.6. VERSIONING DOWN TO SOFTWARE VERSION 1.4 RESOLVES THE ISSUE. THE SAMPLE PREPARATION SYSTEM PS-10 IS A FULLY AUTOMATED, USER-CONFIGURABLE, OPEN SYSTEM INTENDED FOR USE TO PREPARE HUMAN SPECIMENS FOR SUBSEQUENT ANALYSIS ON FLOW CYTOMETERS. THE SYSTEM PIPETTES SPECIMENS, REAGENTS, LYSE AND BUFFER SOLUTIONS TO PREPARE SAMPLES FOR FLOW CYTOMETRIC ANALYSIS. A VARIETY OF ANTIBODY REAGENT VIALS MAY BE USED FOR SAMPLE PREPARATION. OMISSION OF THE PROBE WASH STEP AND POTENTIAL ANTIBODY CARRY-OVER MAY LEAD TO POSSIBLE ERRONEOUS REPRESENTATION OF ANTIGEN MARKERS IN A SAMPLE AND THUS GENERATE ERRONEOUS RESULTS IN SUBSEQUENT FLOW CYTOMETRY ANALYSIS. IF THE INCORRECT RESULT IS OVERLOOKED AND REPORTED, IT MAY LEAD TO MISDIAGNOSIS AND INCORRECT TREATMENT. THE RISK TO HEALTH IS DETERMINED BY THE USER'S APPLICATION IN FLOW CYTOMETRY ANALYSIS, THE INTENDED PURPOSE OF THE CLINICAL TEST. NO MISDIAGNOSIS AND/OR INCORRECT TREATMENT HAVE BEEN REPORTED. PER SEU, THE CUSTOMER CONFIRMED FALSE POSITIVE RESULTS HAD BEEN GENERATED IN RANDOM OCCURRENCES SINCE THE DEVICE SOFTWARE UPGRADE TO VERSION 1.6. APPROXIMATELY 1500 SAMPLES HAD BEEN PROCESSED. THE CUSTOMER PERFORMED A REVIEW OF ALL AFFECTED SAMPLES AND DETERMINED 26 SAMPLES WERE AFFECTED AND SHOWED FALSE POSITIVE CELL POPULATIONS. ALL AFFECTED SAMPLES WERE EITHER IDENTIFIED DURING THE FIRST REANALYSIS BY THE CUSTOMERS AND THEREFORE PREPARED AGAIN, OR NOT IDENTIFIED BUT WITHOUT IMPACT ON THE FINAL RESULT. THE CUSTOMER CONFIRMED NO ERRONEOUS RESULTS WERE ISSUED TO ANY PROVIDERS. THERE WAS NO REPORT OF SERIOUS INJURY OR DEATH DUE TO THE EVENT. SYSMEX AMERICA INCORPORATED, SAI, BECAME AWARE OF THE EVENT ON 12.17.2024. ON 12.23.2024, SYSMEX CORPORATION JAPAN (S-CORP), THE LEGAL MANUFACTURER OF THE PS-10, INITIATED A FIELD CORRECTIVE ACTION (FCA) 2422. ON 1.6.2025, SAI RELEASED PRODUCT NOTIFICATION (PN) CF-07577 TO CUSTOMERS AND INITIATED SAI FIELD CORRECTIVE ACTION (FCA) 2024-004-C. THIS EVENT IS DEEMED REPORTABLE TO THE FDA DUE TO A PRODUCT PROBLEM, PS-10 SOFTWARE VERSION 1.5 AND SOFTWARE VERSION 1.6 SOFTWARE DEFECT CAUSING MISSED WASH SEQUENCES AFFECTING SUBSEQUENT FLOWCYTOMETRY RESULT ACCURACY, WHERE AN FCA IS BEING PERFORMED TO PREVENT THE RISK OF HARM TO PATIENTS.

    Description of Event or Problem · 0

    A SOFTWARE DEFECT WAS IDENTIFIED IN SAMPLE PREPARATION SYSTEM PS-10 SOFTWARE VERSION 1.5 AND SOFTWARE VERSION 1.6, WHERE OMISSION OF THE PROBE WASH STEP AND POTENTIAL ANTIBODY CARRY-OVER MAY LEAD TO POSSIBLE ERRONEOUS REPRESENTATION OF ANTIGEN MARKERS IN A SAMPLE AND THUS GENERATE ERRONEOUS RESULTS IN SUBSEQUENT FLOW CYTOMETRY ANALYSIS. THERE HAS BEEN NO REPORT OF INCORRECT TREATMENT, SERIOUS INJURY OR DEATH DUE TO THE PRODUCT PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364201 SYSMEX PS-10 PS-10 SAMPLE PREPARATION SYSTEM PER SYSMEX CORPORATION PS-10 04987562501908

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown