BD FACSLYRIC¿
Report
- Report Number
- 2916837-2023-00035
- Event Type
- Malfunction
- Date Received
- February 15, 2023
- Date of Event
- January 19, 2023
- Report Date
- June 8, 2023
- Manufacturer
- BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
- Product Code
- OYE
- PMA / PMN Number
- K201814
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H.6 INVESTIGATION SUMMARY ¿ SCOPE OF ISSUE: THE SCOPE OF ISSUE IS ONLY LIMITED TO FACSLYRIC 3L10C INSTRUMENT, PART # 659180, AND SERIAL # (B)(4). ¿ PROBLEM STATEMENT: THE CUSTOMER REPORTED A COMPLAINT REGARDING ERRONEOUS RESULTS ASSOCIATED WITH LYMPHOCYTE COUNT PROBLEMS THAT OCCURRED ON (B)(6) 2023. ERRONEOUS RESULTS CAN NEGATIVELY IMPACT PATIENT DIAGNOSIS AND TREATMENT. THE INSTRUMENT WAS REPAIRED AND FOUND TO BE FUNCTIONING AS EXPECTED, AND NEITHER THE CUSTOMER NOR ANY PATIENTS WERE HARMED BY THESE ERRONEOUS RESULTS. ¿ MANUFACTURING DEFECT TREND: THERE ARE 0 QNS (QUALITY NOTIFICATIONS) RELATED TO THE REPORTED ISSUE FOR PART # 659180. DATE RANGE FROM 27JAN2022 TO DATE 27JAN2023. ¿ MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW: DHR PART # 659180, SERIAL # (B)(4), FILE # (B)(4) WAS REVIEWED. THE INSTRUMENT MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. ¿ COMPLAINT HISTORY REVIEW: THERE ARE 10 COMPLAINTS RELATED TO THE ISSUE OF UNEXPECTED RESULTS FOR PART # 659180 (FILTERED USING AS REPORTED CODE 1: ¿RESULT - UNEXPECTED¿); DATE RANGE FROM 27JAN2022 TO DATE 27JAN2023. ¿ RETURNED SAMPLE ANALYSIS: A RETURN SAMPLE WAS NOT REQUESTED FOR EVALUATION BECAUSE NO PARTS WERE REPLACED. ¿ SERVICE HISTORY REVIEW: REVIEW OF RELATED WORK ORDER #: (B)(4). INSTALL DATE: 19JUN2019. DEFECTIVE PART NUMBER: N/A. WO-02825591 NOTES: SUBJECT / REPORTED: 659180 - FACSLYRIC - LYMPHOCYTE COUNT PROBLEMS. PROBLEM DESCRIPTION: THE CLIENT REPORTS THAT FOR A WEEK, VARIOUS SAMPLES HAVE SHOWN HIGHER LYMPHOCYTE COUNT VALUES THAN THOSE REVEALED BY THE BLOOD COUNT. WORK PERFORMED: CUSTOMER VISIT 09.02.2023 AN INTERVENTION HAS BEEN PERFORMED WHICH INCLUDES: - FLOWCELL OPTICAL GEL REGENERATION. - MONTHLY CLEAN. - OPTICAL ALIGNMENT. - FLUIDICS CONTROL. - CREATE LW/LNW REFERENCE SETTING. - DATABASE MAINTENANCE. FINAL CHECK: - CHECK CORRECT FUNCTIONALITY OF THE LOADER MODULE. - SENSITIVITY / SEPARATION VERIFIED WITH 8-PEAK BEADS. - CQC PERFORMED SUCCESSFULLY. - PQC PERFORMED SUCCESSFULLY. - ABORT COUNT TEST PERFORMED SUCCESSFULLY. - DAILY CLEAN PERFORMED SUCCESSFULLY. - VERIFICATION OF LASER SAFETY. THE INSTRUMENT IS PERFORMING WITHIN THE EXPECTED SPECIFICATIONS AND IS READY TO USE WITHOUT RESTRICTIONS. THE SERVICE REPORT HAS BEEN SENT TO THE CUSTOMER BY EMAIL FOR SIGNATURE. CAUSE: FLOWCELL OPTICAL GEL. SOLUTION: NONE. PART(S) REPLACED: N/A. LABELING / PACKAGING REVIEW: N/A. RISK ANALYSIS: RISK MANAGEMENT FILE PART # (B)(4), REV. 08/VERS. AB, BD FACSLYRIC SYSTEM RISK ANALYSIS WAS REVIEWED. NO NEW HAZARDS HAVE BEEN IDENTIFIED AND THE CURRENT MITIGATION IS SUFFICIENT. HAZARD(S) IDENTIFIED? YES / NO. AZURE ID: 281094. HAZARD ID #: LIBIVD-RA 3.1.201. HAZARD: HIGH ABSOLUTE COUNT OF CELLS REPORTED FOR CLINICAL ASSAYS (LNW). CAUSE: HIGH ABSOLUTE COUNT DUE TO EXCESSIVE ABORTS OF TRUCOUNT BEADS CAUSED BY DIRTY OR POORLY COUPLED FLOW CELL. NOTE: HIGH ABORT COUNT FOR LNW ASSAYS MAY BE CAUSED BY EXCESSIVE RED LASER SCATTER GETTING INTO PERCP CY5.5 CHANNEL. HARMFUL EFFECTS: ARTIFICIALLY HIGH ABSOLUTE CELL COUNT DATA WILL BE REPORTED LEADING TO INACCURATE CLINICAL DIAGNOSIS. RESIDUAL PROBABILITY: 1. RESIDUAL SEVERITY: 4. RESIDUAL RISK INDEX: 4. ¿ POTENTIAL CAUSES: BASED ON THE INVESTIGATION RESULTS, THE POTENTIAL CAUSE WAS DETERMINED TO BE DETERIORATED FLOW CELL OPTICAL GEL. ¿ INVESTIGATION RESULT / ANALYSIS: THE INVESTIGATION WAS PERFORMED AND BASED ON THE REVIEW OF THE COMPLAINT TREND, DEFECT TREND, DHR, RISK ANALYSIS, AND SERVICEMAX, THE POTENTIAL CAUSE WAS DETERMINED TO BE DETERIORATED FLOW CELL OPTICAL GEL. IN RESPONSE TO THE CUSTOMER¿S COMPLAINT REGARDING THE INSTRUMENT YIELDING HIGH LYMPHOCYTE COUNT VALUES COMPARED TO THOSE REVEALED BY COMPLETE BLOOD COUNT, AN FSE (FIELD SERVICE ENGINEER) WENT ONSITE TO INVESTIGATE AND PERFORM TROUBLESHOOTING. THE FSE ADDED NEW FLOW CELL OPTICAL GEL AND PERFORMED OTHER MAINTENANCE ACTIVITIES INCLUDING, BUT NOT LIMITED TO, THE MONTHLY CLEAN, OPTICAL ALIGNMENT, FLUIDICS CONTROL, AND DATABASE MAINTENANCE. THE OPTICAL GEL IS USED IN THE FLOW CELL ASSEMBLY AND PREVENTS REFRACTION- AND/OR REFLECTION-RELATED LOSSES BY ADHERING THE OBJECTIVE LENS TO THE CUVETTE WHERE THE SAMPLE INTERACTS WITH THE LASER. THEREFORE, DETERIORATED GEL CAN INTERFERE WITH LIGHT DETECTION AND PRODUCE INCORRECT RESULTS. AFTER THE REPAIRS, THE FSE TESTED THE INSTRUMENT BY CHECKING THE FUNCTIONALITY OF THE LOADER MODULE, PERFORMING QC TESTS ETC., AND CONFIRMED THAT THE INSTRUMENT WAS WORKING AS PER BD SPECIFICATIONS WITH NO FURTHER UNEXPECTED CELL COUNT ISSUES AND WAS READY FOR USE. ALTHOUGH THIS ISSUE DID PRODUCE ERRONEOUS RESULTS ON PATIENT SAMPLES, IT WAS CONFIRMED THAT THERE WAS NO DELAY IN PATIENT DIAGNOSIS OR TREATMENT DUE TO THIS ISSUE. NO PATIENT OR USER WAS HARMED OR INJURED DUE TO THIS ISSUE. PROPER DAILY AND MONTHLY MAINTENANCE PROCEDURES CAN BE FOUND UNDER ¿MAINTENANCE¿ IN THE USER GUIDE; BD FACSLYRIC¿ SYSTEM INSTRUCTIONS FOR USE, #23-21284, REV. 04/VERS. B, STARTING PAGE 181. THE SAFETY RISK OF THIS HAZARD HAS BEEN IDENTIFIED TO BE WITHIN THE ACCEPTABLE LEVEL. ¿ CONCLUSION: BASED ON THE INVESTIGATION RESULTS, THE COMPLAINT WAS CONFIRMED AND THE POTENTIAL CAUSE OF THE HIGH LYMPHOCYTE COUNT WHICH CAUSED ERRONEOUS RESULTS WAS DETERMINED TO BE DETERIORATED FLOW CELL OPTICAL GEL. THE FSE PERFORMED VARIOUS ACTIVITIES INCLUDING ADDING NEW GEL AND PERFORMING CLEANS AND OPTICAL ALIGNMENT. THE INSTRUMENT WAS THEN TESTED AND CONFIRMED TO BE FUNCTIONING AS EXPECTED. NO ONE WAS HARMED OR INJURED, AND NO MEDICAL DIAGNOSIS OR TREATMENT WAS PERFORMED BASED ON THE ERRONEOUS RESULTS. THE SAFETY RISK OF THIS HAZARD HAS BEEN IDENTIFIED TO BE WITHIN THE ACCEPTABLE LEVEL. BASED ON THE INVESTIGATION RESULTS, A CAPA IS NOT REQUIRED BECAUSE THE ISSUE WAS RESOLVED AND THERE WAS NO IMPACT TO CUSTOMER AND PATIENT HEALTH OR SAFETY. ¿ SUPPORTING DOCUMENT: N/A.
INITIAL REPORTER E-MAIL: (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT WHILE USING THE BD FACSLYRIC¿ THAT THERE WERE ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? YES. THE CLIENT REPORTS THAT FOR A WEEK, VARIOUS SAMPLES HAVE SHOWN HIGHER LYMPHOCYTE COUNT VALUES THAN THOSE REVEALED BY THE BLOOD COUNT.
IT WAS REPORTED THAT WHILE USING THE BD FACSLYRIC¿ THAT THERE WERE ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? YES. THE CLIENT REPORTS THAT FOR A WEEK, VARIOUS SAMPLES HAVE SHOWN HIGHER LYMPHOCYTE COUNT VALUES THAN THOSE REVEALED BY THE BLOOD COUNT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1204878 | BD FACSLYRIC¿ | NA | OYE | BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |