BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XEVO

    MDR report key: 13655992 · Received March 2, 2022

    Report

    Report Number
    1218959-2022-00001
    Event Type
    Malfunction
    Date Received
    March 2, 2022
    Date of Event
    August 9, 2021
    Report Date
    August 9, 2021
    Manufacturer
    WATERS CORPORATION
    Product Code
    DOP
    UDI-DI
    00816776020162
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EN
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: INVESTIGATION HAS SHOWN THAT THIS VULNERABILITY HAS EXISTED IN THE PRODUCT SINCE 2000 WITH NO RECORDED OCCURRENCES OF THIS SUSCEPTIBILITY PRIOR TO THIS COMPLAINT NOR ANY ALLEGED MISDIAGNOSIS SINCE THE PRODUCT RELEASED (INCLUDING THIS COMPLAINT). THE LIKELIHOOD OF THE FAULT CAN DEPEND ON MANY VARIABLES INCLUDING (BUT NOT LIMITED TO) THE COMPUTER HARDWARE AND SOFTWARE DEALING WITH THE FILE SYSTEM AND THE WINDOWS OPERATING SYSTEM. HOWEVER, THE PROBABILITY CONSIDERED FOR THE SYSTEM AS A WHOLE (AND NOT THE SOFTWARE IN ISOLATION) WAS IDENTIFIED AS NOT LIKELY. DETECTABILITY WOULD BE EFFECTIVE IN THIS CIRCUMSTANCE WITH THE COMBINATION OF QC TRACKING AND DATA REVIEW; HAZARD DETECTION BY RISK CONTROL VERY LIKELY. INVESTIGATION FOUND THAT THE CODE ALLOWS FOR A RACE CONDITION, WHERE THE SYSTEM'S SUBSTANTIVE BEHAVIOR IS DEPENDENT ON THE SEQUENCE OR TIMING OF OTHER UNCONTROLLABLE EVENTS. THE CODE COULD RESULT IN THE REFRESH OCCURRING BEFORE THE PROCESSING HAS COMPLETED. TO PREVENT THIS ISSUE OCCURRING, CUSTOMERS SHOULD PRESS F5 / MANUAL REFRESH AT THE END OF THEIR BATCH OR REOPEN THE DATA FILE TO ENSURE DATA IS SHOWN IN THE BROWSER FULLY. BECAUSE OF THE DANGER TO PATIENTS IF THE MISSING ANALYTE IS NOT DETECTED, THIS IS CATEGORIZED AS A SERIOUS INCIDENT. AS SUCH, IT IS CONSIDERED TO BE A REPORTABLE EVENT. DESCRIPTION OF REMEDIAL ACTION/CORRECTIVE ACTION: THIS ISSUE HAS SINCE BEEN CORRECTED WITHIN THE CODE FOR SCN 1024; AFTER WRITING THE NRF FILE, WE NOW CALL CLOSE() WHICH FLUSHES IT OUT OF THE INTERNAL PROCESS MEMORY COPY OF THE FILE INFORMATION INTO THE OPERATING SYSTEM FILE SYSTEM CACHE. THIS ISSUE REQUIRED THE FIELD ACTION. IN THIS CASE, THE FIELD ACTION WOULD TAKE THE FORM OF A CUSTOMER NOTIFICATION OUTLINING THE STEPS THAT SHOULD BE TAKEN TO PREVENT THIS EVENT AND REITERATING THE RELEVANT PORTIONS OF THE OVERVIEW AND MAINTENANCE GUIDE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTS THAT THE LAST COMPOUNDS IN THE LAST SAMPLE OF A BATCH SOMETIMES DOES NOT SHOW THE RESULTS PROPERLY WHEN USING AUTO REFRESH DUE TO A RACE CONDITION IN THE CODE. THE NEOLYNX. EXE PROGRAM RUNS AFTER EACH SAMPLE FINISHES ACQUIRING AND PROCESSES EACH INJECTION. THE CUSTOMER STARTS THEIR RUN, ANALYSES THE RESULTS AS ACQUIRED BY OPENING THE BROWSER & CHECKING INTENSITIES, THEN LEAVES THE BROWSER OPEN WITH AUTO-REFRESH ENABLED. WITH THE CUSTOMER'S BROWSER SET TO AUTO-REFRESH, NEOLYNX SENDS THE RESULTS TO THE BROWSER AS IT PROCESSES. A VULNERABILITY IN THE SOFTWARE MAY CAUSE NEOLYNX. EXE TO TELL THE BROWSER SOFTWARE TO REFRESH ITS DISPLAY BEFORE ALL THE DATA HAS FINISHED WRITING TO THE DISK. WHEN THIS HAPPENS, THE LAST RESULT IS INCOMPLETE IN THE BROWSER DISPLAY (BUT NOT IN THE RESULT FILE - NRF). THE SPECTRUM WINDOW IS NOT COMPLETELY LOADED, LOOKS BLANK AND THE FINAL CHANNELS OF THE LAST FUNCTION CAN BE MISSING. AT THE END OF THE RUN, THE CUSTOMER CHECKS FOR ERROR MESSAGES, REVIEWS THE "FAIL" FLAGGED SAMPLES ONLY AND PUSHES THE DATA LOADED TO LIMS. THE BROWSER ONLY SENDS THE DATA THAT IT HAS LOADED, SO THE ELECTRONIC FILE TO LIMS WILL NOT SHOW THE LAST DATA TRANSITIONS. IF THOSE LAST FUNCTIONS ARE FAILS, THEY WILL NOT BE FLAGGED AS SUCH IN THE BROWSER (SIMULATED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787314 XEVO XEVO TQD IVD DOP WATERS CORPORATION 186005833IVD N/A 00816776020162

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown