BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXLAB

    MDR report key: 8487386 · Received April 5, 2019

    Report

    Report Number
    3010825766-2019-00003
    Event Type
    Malfunction
    Date Received
    April 5, 2019
    Date of Event
    October 25, 2018
    Report Date
    April 16, 2020
    Manufacturer
    INPECO SA
    Product Code
    CEM
    PMA / PMN Number
    K121012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA (MARCH 30, 2020): THE RECALL REFERENCE NUMBER REPORTED IN SECTION H.10 OF THE MDR 3010825766-2019-00003 SUPPLEMENTAL #1 HAS TO BE CORRECTED: THE NUMBER OF THE RECALL SUBMITTED BY INPECO TO IMPLEMENT THE CORRECTIVE ACTIONS IS 3010825766-03/30/20-002 - C. ALL THE OTHER INFORMATION INCLUDED IN THE PREVIOUS REPORTS IS CONFIRMED AND, FOR THIS REASON, NOT REPEATED ALSO IN THIS REPORT.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THE ARCHITECT CSYSTEMS (C8000 AND C16000) PRIORITIZES THE PROCESSING OF SAMPLE TUBES MANUALLY LOADED ON THE ANALYZER OVER SAMPLE TUBES ROUTED TO THE ARCHITECT CSYSTEMS INTERFACE MODULE (IM) BY THE AUTOMATION SYSTEM. WHEN SAMPLE TUBES ARE MANUALLY LOADED THE ANALYZER STOPS TO PROCESS SAMPLES RECEIVED FROM THE INTERFACE MODULE. THE ARCHITECT CSYSTEMS INTERFACE MODULE FIRMWARE IS CONFIGURED TO GENERATE THE TOTAL TIMEOUT EXPIRED ERRORS (CODE 7083 OR 3983) IF THE SAMPLING COMPLETE NOTIFICATION IS NOT RECEIVED FROM THE ARCHITECT CSYSTEMS WITHIN THE EXPECTED TIMEOUT (20 MINUTES). THE INVESTIGATION OF THE EVENT OCCURRED ON FIELD SHOWED THAT THE TOTAL TIMEOUT EXPIRED ERRORS CAN BE GENERATED ALSO WHEN A SAMPLE TUBE IS AT THE SAMPLING GATE OF THE ARCHITECT CSYSTEMS INTERFACE MODULE AND ONE OF THE FOLLOWING SCENARIOS OCCURS: SAMPLE CAROUSEL OF AN ARCHITECT CSYSTEMS IS LEFT FOR MORE THAN 20 MINUTES OPEN WITHOUT PUTTING THE CSYSTEMS INTERFACE MODULE OFFLINE. RUNNING MULTIPLE TUBES OR QC IN THE SAMPLE CAROUSEL OF AN ARCHITECT CSYSTEMS WITHOUT PUTTING THE CSYSTEMS INTERFACE MODULE OFFLINE FOR MORE THAN 20 MINUTES. THE CURRENT STEP-BY-STEP ERROR RECOVERY OF TOTAL TIMEOUT EXPIRED ERROR DISPLAYED ON AUTOMATION SYSTEM IUI HAS BEEN EVALUATED NOT APPROPRIATE: IT ALLOWS THE RELEASE OF THE SAMPLE TUBES PRESENT IN THE SECONDARY LANE OF THE ARCHITECT CSYSTEM INTERFACE MODULE, EVEN IF THE ANALYZER HAS STILL TO COMPLETE THE SAMPLING PROCEDURE WITH ADDITIONAL ASPIRATIONS ON THE SAMPLE TUBE PRESENT AT THE SAMPLING POSITION WHEN THE PROCESSING OF SAMPLE TUBES ON THE AUTOMATION SYSTEM WAS INTERRUPTED. IT IS POSSIBLE THAT THE PROBE ATTEMPTS TO ASPIRATE WITH NO SAMPLE TUBE AT THE SAMPLING POSITION, THUS GENERATING ASPIRATION ERROR OR COMPLETES THE FOLLOWING ASPIRATIONS ON DIFFERENT TUBES IN THE IM QUEUE WHILE THEY ARE PASSING THROUGH THE SAMPLING POSITION. IN ACCORDANCE WITH THE LEGAL MANUFACTURER OF ARCHITECT CSYSTEM ANALYZER INPECO HAS DECIDED THAT THE CHANGE OF TIMEOUT EXPIRED ERROR RECOVERY IS THE MOST EFFECTIVE WAY TO AVOID THE RISK OF ERRONEOUS AND DELAYED RESULTS. INPECO HAS SUBMITTED THE RECALL #3010825766 - 03/23/20 - 001 - C TO IMPLEMENT THE FOLLOWING CORRECTIVE ACTIONS: THE UPGRADE TO THE SOFTWARE DRIVER C16 1.6 WHICH INCLUDES THE MODIFIED ERROR RECOVERY. THE DISTRIBUTION OF THE UPDATED OPERATIONS MANUAL (ARCHITECT C8000/C16000 IM SECTION) WHICH SPECIFIES THAT THE OPERATOR HAS TO SET THE INTERFACE MODULE OFFLINE BEFORE MANUALLY LOADING THE SAMPLE TUBES DIRECTLY ON THE ANALYZER.

    Additional Manufacturer Narrative · 1

    INPECO DISTRIBUTOR IS IN CHARGE OF THE SERVICE SUPPORT ACTIVITIES ON FLEXLAB AUTOMATION SYSTEM INSTALLED AT HUSLAB. SPECIFICALLY, INPECO DISTRIBUTOR IS RESPONSIBLE FOR THE FIRST ASSISTANCE: IN CASE A DEEPER INVESTIGATION OR A PRODUCT DESIGN CHANGE IS NEEDED TO FIX THE ISSUE, INPECO DISTRIBUTOR CONTACTS INPECO SERVICE TEAM. FOR THE PROBLEM DESCRIBED IN THE CUSTOMER REPORT, INPECO HAS NOT BEEN DIRECTLY INVOLVED. AT PRESENT THE INVESTIGATION IS STILL ONGOING AND THE ROOT CAUSE HAS NOT BEEN IDENTIFIED YET. INPECO IS WORKING WITH THE DISTRIBUTOR IN ORDER TO GET FURTHER INFORMATION FROM THE CUSTOMER AND REPRODUCE, IF POSSIBLE, THE PROBLEM IN HOUSE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO THE FINNISH COMPETENT AUTHORITY AN INADEQUATE SAMPLE TUBES MANAGEMENT IN CASE OF ABBOTT C16000 ANALYZER TOTAL TIMEOUT ERROR MESSAGE SENT FROM THE ANALYZER TO THE FLEXLAB AUTOMATION SYSTEM THAT MAY LEAD TO SAMPLE RESULTS MISMATCH AND SAMPLE CROSS CONTAMINATION. NO INCIDENT HAS BEEN REPORTED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282034 FLEXLAB LABORATORY AUTOMATION SYSTEM CEM INPECO SA

    Patients

    Seq Age Sex Outcome Treatment
    1