BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUIOS CL FLOW CYTOMETER

    MDR report key: 6703630 · Received July 11, 2017

    Report

    Report Number
    1061932-2017-00008
    Event Type
    Malfunction
    Date Received
    July 11, 2017
    Date of Event
    May 22, 2017
    Report Date
    September 22, 2017
    Manufacturer
    BECKMAN COULTER IRELAND
    Product Code
    OYE
    PMA / PMN Number
    K071681
    Removal / Correction Number
    Z-3135-2017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE WAS SENT TO THIS ACCOUNT FOR AN ISSUE REGARDING THE PROBE. WHILE ON SITE THE FIELD SERVICE ENGINEER (FSE) FOUND THAT THE INSTRUMENT WAS NOT CONFIGURED PROPERLY. THE FSE RECONFIGURED THE INSTRUMENT TO THE PROPER STATUS. THE REPAIRS WERE VERIFIED. (B)(4).

    Additional Manufacturer Narrative · 1

    BEC INTERNAL IDENTIFIER (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTION TO DATE RECEIVED BY THE MANUFACTURER : 9/22/2017.

    Additional Manufacturer Narrative · 1

    CORRECTION. DESCRIBE EVENT OR PROBLEM - FURTHER INVESTIGATION FOUND THAT ERRONEOUS PATIENT RESULTS WERE REPORTED OUTSIDE THE LABORATORY. COMMON DEVICE NAME - FLOW CYTOMETER. PRODUCT CODE - OYE. DATE RECEIVED BY THE MANUFACTURER - 9/20/2017 CHECKED RECALL, NOTIFICATION AND MODIFICATION/ADJUSTMENT. REPORTING NUMBER - Z- 3135-2017. THE FIELD SERVICE ENGINEER (FSE) FOUND THAT THE SAMPLE PREP PROBE (SAMPLE PROBE) ON THE AQUIOS CL FLOW CYTOMETER SERIAL NUMBER (B)(4) WAS INCORRECTLY CONFIGURED TO SET THE MULTILOAD START AND END TO THE SAME VALUE. THE INSTRUMENT WAS RECONFIGURED AND REPAIRED BY THE FSE. THE MISCONFIGURATION CAUSED THE INSTRUMENT TO SAMPLE ONLY FROM POSITION "1" (ONE) IN THE CASSETTE. THE FIRST SAMPLE FOR EACH CASSETTE WOULD BE CORRECT; HOWEVER, EACH SUBSEQUENT PATIENT SPECIMEN IN EACH CASSETTE WOULD BE IDENTIFIED BY ITS CORRECT BARCODE, BUT WOULD BE ASPIRATED AND ANALYZED WITH SAMPLE FROM THE FIRST POSITION IN THE CASSETTE. THE INSTRUMENTS ARCHIVED DATA BETWEEN SEPTEMBER 2016 AND JUNE 2017 WAS ANALYZED BY THE SOFTWARE ENGINEERS. THE AVAILABLE PATIENT RESULTS ANALYZED CAN BE DIVIDED INTO FOUR SEPARATE GROUPS: 681 RESULTS HAD BEEN OBTAINED FROM CASSETTE TUBE POSITION 1 OR FROM SINGLE-TUBE LOADER AND ARE RESULTS THAT ARE CORRECTLY IDENTIFIED, 2,205 RESULTS HAVE BEEN OBTAINED FROM CASSETTE TUBE POSITIONS 2-5 AND ARE RESULTS THAT ARE MISIDENTIFIED AND WILL REQUIRE FURTHER FOLLOW-UP, 1,528 RESULTS WERE RUNS FROM AN UNKNOWN CASSETTE TUBE POSITION DUE TO THE RUN BEING MARKED AS REVIEWED IN THE SOFTWARE AND 2,692 RESULTS WERE RUNS FROM AN UNKNOWN CASSETTE TUBE POSITION DUE TO AN NHLS ARCHIVE EVENT WHICH DELETED THE REQUIRED RECORDS TO IDENTIFY CASSETTE TUBE POSITION. THE CUSTOMER IS PERFORMING THE PATIENT IMPACT ASSESMENT. BECKMAN COULTER INITIATED A RECALL THROUGH FIELD ACTION FA-31696. BECKMAN COULTER INTERNAL IDENTIFIER FOR THIS REPORT IS (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION REGARDING THE EVENT: SETTINGS ON THE AQUIOS INSTRUMENT WERE CORRECTLY CONFIGURED ON (B)(6) 2017. ALL OF THE OTHER 19 AQUIOS INSTRUMENTS FOR THE CUSTOMER WERE CONFIRMED TO HAVE THE CORRECT CONFIGURATION. AS PART OF THE INVESTIGATION THE INSTRUMENT LOGS WERE REVIEWED FOR ALL 20 AQUIOS CL INSTRUMENTS LOCATED AT THE NHLS PATHOLOGY GROUP. THE OVERALL RESULTS FROM THIS INITIAL INVESTIGATION SHOW THAT NO OTHER INSTRUMENT HAD BEEN MISCONFIGURED. BEC CONTACTED EACH OF THE 19 OTHER CUSTOMER LABORATORY SITES WITH AN AQUIOS CL SYSTEM, CHECKED THE OPERATING LOGS AND DETERMINED THAT NONE OF THE NINETEEN OTHER UNITS BELONGING TO NHLS WAS MISCONFIGURED. THIS CONFIRMS THAT THE ISSUE REPORTED IN THE FIELD SAFETY NOTICE. (FA-31696) IS NOT PRESENT ON ANY OTHER NHLS INSTRUMENTS AND TO DATE, THIS ISSUE HAS NOT BEEN FOUND ON ANY OTHER CUSTOMER INSTRUMENTS WORLDWIDE. TO PREVENT THE MISCONFIGURATION ERROR FROM RECURRING, BECKMAN COULTER IMPLEMENTED AN IMPROVED SERVICE PROCEDURE (TECHNICAL UPDATE) IN AUGUST 2017 FOR AQUIOS PROBE ALIGNMENT VERIFICATION THAT PROVIDES DETAILED STEP BY STEP INSTRUCTIONS TO TRAINED AQUIOS CL FIELD SERVICE ENGINEERS (FSE) ON HOW TO VERIFY THAT THE SAMPLE PREP PROBE HAS BEEN ALIGNED PROPERLY. THIS ENHANCED SAMPLE PREP PROBE ALIGNMENT VERIFICATION PROCEDURE WAS DEVELOPED TO ENSURE ANY MISCONFIGURATION OF THE PREP PROBE WOULD BE CAUGHT AND CORRECTED BY THE FSE BEFORE TURNING THE INSTRUMENT TO THE CUSTOMER. ALL BECKMAN COULTER FSES( FIELD SERVICE ENGINEERS) ON THE CONTINENT OF (B)(6) HAVE BEEN TRAINED ON THIS PROCEDURE. BEGINNING AUGUST 16, 2017, BEC INITIATED A GLOBAL FIELD ACTION URGENT FIELD SAFETY NOTICE (FSN-31696), INFORMING CUSTOMERS OF THE POTENTIAL FOR THIS MISCONFIGURATION TO OCCUR AND HOW TO DETECT THE PRESENCE OF THE MISCONFIGURATION. ADDITIONALLY, EACH AQUIOS CL CUSTOMER IS BEING CONTACTED INDIVIDUALLY TO RUN THE AUTO LOADER QC TESTING THAT WILL DETERMINE WHETHER THE ERROR EXISTS AND TO CONFIRM WITH THE PROPER CONFIGURATION. THIS IS A TEMPORARY COUNTERMEASURE UNTIL A PERMANENT SOLUTION IS DEVELOPED AND TESTED THAT WILL AUTOMATICALLY DETECT A MISCONFIGURATION AND ALERT THE USER TO CONTACT BEC FOR SERVICE TO CORRECT THE ISSUE BEFORE THE ANALYZER CAN BE USED. BECKMAN COULTER IMPLEMENTED A SERVICE MOD (MODIFICATION) IN AUGUST 2017 TO CONFIRM AND DOCUMENT THAT THE SAMPLE PREP PROBE IS PROPERLY CONFIGURED ON ALL CURRENTLY INSTALLED AQUIOS CL INSTRUMENTS WORLDWIDE. THIS MOD WILL BE PERFORMED BY THE BECKMAN COULTER FSE EITHER ON-SITE OR REMOTELY VIA PHONE WORKING WITH THE LABORATORY STAFF AND IS EXPECTED TO BE COMPLETED BY NOVEMBER 2017. BECKMAN COULTER WILL COLLECT AND REVIEW INSTRUMENT QC (QUALITY CONTROL) LOGS VIA SERVICE REQUEST TO DETERMINE IF CORRECT/INCORRECT SETTINGS HAVE BEEN USED. IF THE LOG REVIEW DETERMINES THAT THE SETTING IS INCORRECT, THE FSE WILL GENERATE A CUSTOMER COMPLAINT FOR FURTHER INVESTIGATION AND WILL IMMEDIATELY CORRECT THE SETTINGS. RECOMMENDATION WILL BE PROVIDED TO ANY IMPACTED CUSTOMER(S) TO CONSULT WITH THEIR MEDICAL DIRECTORS FOR REVIEW OF THE RESULTS. AS OF OCTOBER 17, 2017, THE SERVICE MOD IS 73% COMPLETION AND TO DATE, THIS ISSUE HAS NOT BEEN FOUND ON ANY OTHER CUSTOMER INSTRUMENTS WORLDWIDE BECKMAN COULTER IS WORKING ON A PLANNED IMPLEMENTATION OF AQUIOS CL SYSTEM SOFTWARE UPGRADE THAT WILL DETECT AND ALERT THE USER OF ERRONEOUS PROBE SETTINGS. THIS SOFTWARE REVISION THAT WILL INCLUDE A CHECK OF POTENTIAL POSITIONAL ERRORS AS PART OF THE STARTUP ROUTINE. THIS WILL BE ACCOMPLISHED IN THE SYSTEM SOFTWARE BY HAVING IT REVIEW THE POSITIONAL SETTINGS AND COMPARE IT TO EXPECTED VALUES, THUS ELIMINATING THE POTENTIAL FOR THIS ERROR. THE UPGRADED SOFTWARE IS EXPECTED TO BE IMPLEMENTED BY DECEMBER 2017. THE TASK OF ASSESSING THE SUBGROUP OF PATIENTS REQUIRING RE-TESTING HAS BEEN COMPLETED AND THE CUSTOMER HAS CONCLUDED THAT 74 PATIENTS OF THIS POPULATION HAD BEEN IDENTIFIED FOR RE-TESTING. THE DEPT. OF HEALTH IS REACHING OUT TO THESE PATIENTS AND IS ORGANIZING THE RE-TESTING . WITH THE INFORMATION CURRENTLY AVAILABLE, ANY CHANGE OR AFFECT TO PATIENT TREATMENT CANNOT BE CONFIRMED. CURRENTLY NO CHANGE TO PATIENT TREATMENT HAS BEEN REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE AQUIOS CL FLOW CYTOMETER WAS GENERATING ERRONEOUS RESULTS ON AN UNKNOWN NUMBER OF CD4 SAMPLES. THE CUSTOMER INITIALLY REPORTED A BENT PROBE. THE FIELD SERVICE ENGINEER FOUND THE SYSTEM WAS NOT CONFIGURED PROPERLY AND WAS GENERATING ERRONEOUS RESULTS. ERRONEOUS PATIENT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY, HOWEVER, THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION TO THE EVENT.

    Description of Event or Problem · 1

    FURTHER INVESTIGATION FOUND THAT ERRONEOUS PATIENT RESULTS WERE REPORTED OUTSIDE THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481437 AQUIOS CL FLOW CYTOMETER FLOW CYTOMETER OYE BECKMAN COULTER IRELAND NA

    Patients

    Seq Age Sex Outcome Treatment
    1