BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APTIO AUTOMATION

    MDR report key: 22727328 · Received August 6, 2025

    Report

    Report Number
    3010825766-2025-00004
    Event Type
    Malfunction
    Date Received
    August 6, 2025
    Date of Event
    June 30, 2025
    Report Date
    September 19, 2025
    Manufacturer
    INPECO SA
    Product Code
    JQP
    UDI-DI
    07640172342008
    PMA / PMN Number
    K121012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT HAS BEEN INVESTIGATED BY THE DISTRIBUTOR SERVICE ASSISTANCE. BETWEEN 20:41:46 AND 20:47:19 THERE WERE 38 SAMPLES THAT WERE RETURNED FROM CM (NODE 7) WITHOUT COMPLETING THEIR SPIN CYCLE INTO THE THIRD-PARTY CENTRIFUGE. AT 20:24:13 THE SPIN CYCLE BEGAN. ALMOST IMMEDIATELY THE THIRD-PARTY CENTRIFUGE PRODUCED AN ERROR WHICH WAS MAPPED BY THE AUTOMATION SYSTEM WITH THE GENERIC ERROR CODE 2B91 - GENERIC CENTRIFUGE ERROR. THE ERROR RECOVERY ON THE AUTOMATION SYSTEM INTERFACE IS THE FOLLOWING: "THE CENTRIFUGE IS REPORTING AN INTERNAL ERROR. ACCESS THE [DIAGNOSTICS - CENTRIFUGE, BALANCE AND BUCKET] SCREEN. SET THE CENTRIFUGE MODULE <OFF-LINE>. CHECK THE ERROR REPORTED ON THE CENTRIFUGE DISPLAY AND REFER TO CENTRIFUGE OPERATION MANUAL TO RESOLVE THE ISSUE. PRESS THE <INIT CENTRIFUGE> FUNCTION BUTTON. SET THE CENTRIFUGE MODULE BACK <ON-LINE>. IF THE PROBLEM PERSISTS, CONTACT THE SERVICE ASSISTANCE." TO RESTORE THE PROPER FUNCTIONING OF THE CENTRIFUGE, THE RECOVERY HAD TO BE FOLLOWED ON THE THIRD-PARTY CENTRIFUGE PANEL. WHEN THE INPECO CENTRIFUGE MODULE WAS PUT BACK ONLINE, IT PROCEEDED TO RETURN THE SAMPLE TUBES TO THE TRACK CONSIDERING THEM SPUN IN ACCORDANCE WITH THE INFORMATION RECEIVED FROM THE THIRD-PARTY CENTRIFUGE. THE EVENT SEEMS TO HAVE BEEN CAUSED BY AN INCORRECT RECOVERY PERFORMED ON THE CENTRIFUGE. UP TO NOW, IT HAS NOT BEEN POSSIBLE TO CHECK WHAT HAPPENED DURING THE RECOVERY AND TO VERIFY IF THE SAMPLE TUBES WERE ACTUALLY SPUN OR NOT.

    Additional Manufacturer Narrative · 0

    THE INITIAL REPORT 3010825766-2025-00004 WAS SENT ON AUGUST 6TH, 2025. ADDITIONAL INFORMATION: ACCORDING TO THE INVESTIGATION THE ERROR PRODUCED BY THE THIRD PARTY CENTRIFUGE WAS "IMBALANCE ERROR". THE CENTRIFUGE OPERATIONS MANUAL REQUIRES TO "REPEAT THE CENTRIFUGATION RUN". THE AUTOMATION SYSTEM CORRECTLY CONSIDERED THE SAMPLE TUBES AS CENTRIFUGED. THE EVENT IS THE RESULT OF A USER ERROR. NO PERFORMANCE ISSUE ON THE INPECO AUTOMATION SYSTEM HAS BEEN IDENTIFIED. NO ADDITIONAL ACTIONS ARE FORESEEN FROM INPECO SIDE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THEY OBSERVED AN ISSUE WITH THE CENTRIFUGE MODULE (CM3, NODE 7) OF THEIR APTIO AUTOMATION SYSTEM. THE CENTRIFUGE MODULE IS THE INTERFACE WHICH CONNECTS THE TRACK TO THE CENTRIFUGE (THIRD-PARTY PRODUCT). ACCORDING TO THE CUSTOMER MULTIPLE SAMPLES WENT TO CM3, LEFT THE MODULE WITHOUT BEING SPUN AND WERE SENT TO A THIRD-PARTY INSTRUMENT (ATELLICA) FOR THE ANALYSIS. SOME OF THE INCORRECT RESULTS WERE REPORTED TO THE PHYSICIAN(S). NO SPECIFIC INFORMATION ABOUT THE PERFORMED TESTS AND THE OBTAINED RESULTS HAVE BEEN PROVIDED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1725266 APTIO AUTOMATION LABORATORY AUTOMATION SYSTEM JQP INPECO SA 07640172342008

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown