BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUIOS CL FLOW CYTOMETER

    MDR report key: 6942640 · Received October 11, 2017

    Report

    Report Number
    1061932-2017-00015
    Event Type
    Malfunction
    Date Received
    October 11, 2017
    Date of Event
    September 11, 2017
    Report Date
    October 5, 2017
    Manufacturer
    BECKMAN COULTER IRELAND
    Product Code
    OYE
    PMA / PMN Number
    K141932
    Removal / Correction Number
    2050012-0928/2017-022C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT RAW DATA FILES [CRD FILES WERE PROVIDED TO THE SUBJECT MATTER EXPERT (SME) OF AQUIOS CL SOFTWARE APPLICATIONS. BECKMAN COULTER SOFTWARE ENGINEERS CONDUCTED AN INVESTIGATION INTO THIS ISSUE AND HAVE DETERMINED THAT THERE IS A POTENTIAL FOR MIS-IDENTIFIED SAMPLES ON THE CUSTOMER'S AQUIOS CL FLOW CYTOMETER RESULTING IN THE GENERATION OF ERRONEOUS RESULTS. ATTAINING THE CUSTOMER'S DATABASE WILL AID IN CONFIRMING AND IDENTIFYING WHICH SAMPLES WERE IMPACTED. BASED ON THE INITIAL ASSESSMENT, THE ISSUE OCCURS BECAUSE THERE IS A MECHANISM BY WHICH THE AQUIOS SOFTWARE WILL GENERATE A DUPLICATE TEST WHEN A TEST QUERY RESPONSE IS RECEIVED FROM THE LABORATORY INFORMATION SYSTEM (LIS) IMMEDIATELY BEFORE THE QUERY TIMEOUT PERIOD EXPIRES. ONCE THE DUPLICATE TEST ORDER IS CREATED, THE SOFTWARE WILL CONTINUE TO CREATE DUPLICATE TESTS AS LONG AS THERE ARE TUBES AVAILABLE IN THE CASSETTE AND IN THE STACKER. ONCE ALL TESTS HAVE BEEN COMPLETED, THE SOFTWARE REVERTS TO NORMAL OPERATION. THE OUTCOME OF HAVING DUPLICATE TESTS IN THE SYSTEM VARIES ACCORDING TO THE NUMBER AND POSITION OF TUBES IN EACH CASSETTE, WHICH, IN TURN, MAY CAUSE THE INSTRUMENT TO RESAMPLE THE SAME TUBE OR DRAW THE SAMPLE FROM ANOTHER TUBE. EACH SAMPLE ID WILL GENERATE ONE OF THE FOLLOWING OUTCOMES: - ONE CORRECT RESULT FOR THE SAMPLE - TWO (OR MORE) CORRECT RESULTS FOR THE SAMPLE - ONE INCORRECT RESULT FOR THE SAMPLE - MISIDENTIFICATION - ONE (OR MORE) INCORRECT RESULTS AND ONE (OR MORE) CORRECT RESULTS FOR THE SAMPLE - MISIDENTIFICATION FOR THIS EVENT THERE WERE FOUR SAMPLES IDENTIFIED AS DUPLICATED. THREE OF THE SAMPLES RESULTS WERE FLAGGED AND ALERTED THE USER TO A POTENTIAL PROBLEM (SAMPLE ID 171981219601, 171981473101 AND 171991189601). THERE WAS ONE ERRONEOUS RESULT (171981369001) THAT WAS NOT FLAGGED. THE ISSUE WAS ESCALATED TO THE BECKMAN COULTER (BEC) SOFTWARE ENGINEERING TEAM. THE PROBLEM IS CURRENTLY UNDER AN ONGOING INVESTIGATION. THERE HAS BEEN NO REOCCURRENCE OF THIS EVENT REPORTED BY THE CUSTOMER TO DATE ((B)(6)2017). BEC INTERNAL IDENTIFIED (B)(4). ADDITIONAL INFORMATION THE RECALL (FA-31978) WHICH INCLUDED NOTIFICATION TO THE CUSTOMER AND INSPECTION OF CUSTOMERS' DEVICE DATA WILL BE UPDATED VIA ADDITIONAL COMMUNICATION TO CUSTOMERS TO ADDRESS THIS NEW FAILURE MODE.

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER SPECIALISTS CONDUCTED AN INVESTIGATION AT THE CUSTOMERS SITE AND DETERMINED THAT THERE IS A POTENTIAL FOR MIS-IDENTIFIED SAMPLES ON THE CUSTOMER'S AQUIOS CL FLOW CYTOMETER RESULTING IN THE GENERATION OF ERRONEOUS RESULTS. THE CUSTOMERS DATA BASE WAS ANALYZED BY SPECIALISTS ON 2017-9-18. THE BEC ENGINEERS REVIEWED THE DATABASE FOR THE IMPACTED AQUIOS CL INSTRUMENT (SERIAL (B)(4)) AND FOUR SAMPLES WERE IDENTIFIED AS DUPLICATE. OF THE FOUR SAMPLES IDENTIFIED AS DUPLICATED THREE OF THE SAMPLES RESULTS WERE FLAGGED BY THE INSTRUMENT AND ALERTED THE USER TO A POTENTIAL PROBLEM ((B)(6)). THERE WAS ONLY ONE ERRONEOUS RESULT ((B)(6)) THAT WAS NOT FLAGGED. THE OUTCOME OF HAVING DUPLICATE TESTS IN THE SYSTEM VARIES ACCORDING TO THE NUMBER AND POSITION OF TUBES IN EACH CASSETTE, WHICH, IN TURN, MAY CAUSE THE INSTRUMENT TO RESAMPLE THE SAME TUBE OR DRAW THE SAMPLE FROM ANOTHER TUBE. EACH SAMPLE ID WILL GENERATE ONE OF THE FOLLOWING OUTCOMES: (1) ONE CORRECT RESULT FOR THE SAMPLE, (2) TWO (OR MORE) CORRECT RESULTS FOR THE SAMPLE, (3) ONE INCORRECT RESULT FOR THE SAMPLE - MISIDENTIFICATION AND (4) ONE (OR MORE) INCORRECT RESULTS AND ONE (OR MORE) CORRECT RESULTS FOR THE SAMPLE - MISIDENTIFICATION. BASED ON THE INITIAL ASSESSMENT, THE ISSUE OCCURS BECAUSE THERE IS A MECHANISM BY WHICH THE AQUIOS SOFTWARE WILL GENERATE A DUPLICATE TEST WHEN A TEST QUERY RESPONSE IS RECEIVED FROM THE LABORATORY INFORMATION SYSTEM (LIS) IMMEDIATELY BEFORE THE QUERY TIMEOUT PERIOD EXPIRES. ONCE THE DUPLICATE TEST ORDER IS CREATED, THE SOFTWARE WILL CONTINUE TO CREATE DUPLICATE TESTS AS LONG AS THERE ARE TUBES AVAILABLE IN THE CASSETTE AND IN THE STACKER. ONCE ALL TESTS HAVE BEEN COMPLETED, THE SOFTWARE REVERTS TO NORMAL OPERATION. BECKMAN COULTER INITIATED A WORLD WIDE MEDICAL DEVICE RECALL ON 2017-10-03 (FA-31978). THERE HAS BEEN NO REOCCURRENCE OF THIS EVENT REPORTED BY THE CUSTOMER TO DATE (2017-10-05). (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE AQUIOS CL CYTOMETER WAS RERUNNING SAMPLES MULTIPLE TIMES WITHOUT BEING PROMPTED. RESULTS SHOWED DUPLICATE/MULTIPLE VALUES WITH THE SAME SAMPLE ID NUMBERS. THERE HAS BEEN NO REPORT OF DEATH, SERIOUS INJURY, OR CHANGE TO PATIENT TREATMENT REPORTED FOR THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE AQUIOS CL CYTOMETER WAS RUNNING DUPLICATE SAMPLE RUNS AFTER UPGRADING THE SOFTWARE FROM VERSION 2.1 TO 2.2. . THE CUSTOMER REPORTED SOME SAMPLES WERE RUNNING TWO TO FOUR TIMES. THERE HAS BEEN NO REPORT OF DEATH, SERIOUS INJURY, OR CHANGE TO PATIENT TREATMENT REPORTED FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721395 AQUIOS CL FLOW CYTOMETER FLOW CYTOMETER OYE BECKMAN COULTER IRELAND NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR