BD FACSLYRIC¿
Report
- Report Number
- 2916837-2023-00088
- Event Type
- Malfunction
- Date Received
- April 4, 2023
- Date of Event
- March 14, 2023
- Report Date
- November 6, 2023
- Manufacturer
- BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
- Product Code
- OYE
- PMA / PMN Number
- K201814
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
INITIAL REPORTER FAX # (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
INVESTIGATION SUMMARY: INVESTIGATION SUMMARY: ¿ SCOPE OF ISSUE: THE SCOPE OF ISSUE IS ONLY LIMITED TO FACSLYRIC 3L12C INSTRUMENT RECEIVED, PART # 663029, AND SERIAL # (B)(6). ¿ PROBLEM STATEMENT: THE CUSTOMER REPORTED A COMPLAINT REGARDING ARTIFACTS IN THEIR MEASUREMENTS ON 14MAR2023. ¿ MANUFACTURING DEFECT TREND: THERE ARE 0 QNS (QUALITY NOTIFICATIONS) RELATED TO THE REPORTED ISSUE WITH PART # 663029. DATE RANGE FROM 14MAR2022 TO DATE 14MAR2023. ¿ DEVICE HISTORY RECORD (DHR) REVIEW: DHR PART # 663029 SERIAL # (B)(6) ,FILE # (B)(4) WAS REVIEWED. THE INSTRUMENT MANUFACTURING DATE IS 14JUL2020 AND INSTRUMENT MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. ¿ COMPLAINT HISTORY REVIEW: THERE ARE 6 COMPLAINTS RELATED TO THE ISSUE OF UNEXPECTED RESULTS FOR PART # 663029. (B)(4). DATE RANGE FROM 14MAR2022 TO DATE 14MAR2023. ¿ RETURNED SAMPLE ANALYSIS: A COMPLAINT SAMPLE WAS NOT REQUESTED TO BE RETURNED BECAUSE NO PARTS WERE REPLACED. ¿ SERVICE HISTORY REVIEW: REVIEW OF RELATED WORK ORDER #: (B)(4); CASE # (B)(4). INSTALL DATE: 23SEP2020 DEFECTIVE PART NUMBER: N/A WORK ORDER NOTES: O SUBJECT / REPORTED: (B)(4) - FACSLYRIC 3L12C INSTRUMENT RECEIVED - CUSTOMER REPORTS ARTIFACTS IN HER MEASUREMENTS O PROBLEM DESCRIPTION: CUSTOMER REPORTS ARTIFACTS IN HER MEASUREMENTS O WORK PERFORMED: TECHNICAL USE FROM 31.03.2023 CARRIED OUT A REPAIR ON BD FACSLYRIC¿ IN THE FIELD OF OPTICS. THIS INCLUDES: -LASER POWER CHECKED. -PQC PROTOCOLS CHECKED FOR DEVIATIONS (LASER DELAY, ASF) -SAMPLE MEASUREMENTS PERFORMED. SYSTEM CHECKED FOR CONTAMINATION/CLOGGING. -SIT FLUSH FUNCTION CHECKED. -FLOW RATES CHECKED. FINAL CONTROL: - SENSITIVITY / SEPARATION TESTED WITH 8-PEAK BEADS. - PQC SUCCESSFULLY EXECUTED. - ABORTION COUNT TEST SUCCESSFULLY PERFORMED. - LASER SAFETY CHECK PERFORMED. THE DEVICE COMPLIES WITH THE SPECIFICATIONS OF THE SYSTEM AND IS READY FOR USE WITHOUT RESTRICTIONS. O CAUSE: NO ERROR COULD BE IDENTIFIED FOR THE PROBLEM DESCRIBED. O SUMMARY: NO PROBLEM WITH INSTRUMENT AFTER DIAGNOSTIC CHECKS, AND THE COMPLAINT RESULTS COULD NOT BE DUPLICATED. THE INSTRUMENT PASSED ALL TESTS AND IS RUNNING AS EXPECTED. THE FSE CONSULTED WITH THE CUSTOMER AND VERIFIED THAT THE PROBLEM DOES NOT OCCUR IN EVERY SAMPLE BUT IS MONITORED AND EVERY ABNORMALITY IS DOCUMENTED. IF THE ISSUE OCCURS AGAIN, THEN AN APPLICATION SPECIALIST WILL BE REQUIRED. ¿ 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 O AZURE ID: 89305 O ID: LIBIVD-RA-379 3.1.103 O REG STATUS: IVD; RUO O HAZARD: INCORRECT RESULTS OR INFORMATION O CAUSE: INCORRECT INFORMATION IN REPORT OR RESULTS. DATA ENTRY ERROR.. O HARMFUL EFFECTS: INCORRECT INTERPRETATION OF RESULTS O RESIDUAL PROBABILITY: 1 O RESIDUAL SEVERITY: 3 O RESIDUAL RISK INDEX: 3 O RESIDUAL RISK EVALUATION: A O NEW HAZARDS: NONE ¿ POTENTIAL CAUSES: BASED ON THE INVESTIGATION, THE POTENTIAL CAUSE OF ARTIFACTS IN THE CUSTOMER¿S MEASUREMENTS, OR INCORRECT RESULTS, COULD NOT BE CONFIRMED. ¿ 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 OF ARTIFACTS IN THE CUSTOMER¿S MEASUREMENTS, OR INCORRECT RESULTS, COULD NOT BE CONFIRMED. THE FSE (FIELD SERVICE ENGINEER) VISITED THE CUSTOMER¿S SITE AND PERFORMED VARIOUS CHECKS ON THE INSTRUMENT AND FOUND NO ISSUES. THE FSE COULD NOT DUPLICATE THE CUSTOMER¿S CLAIMS OF INCORRECT RESULTS. THE FSE CONSULTED WITH THE CUSTOMER AND VERIFIED WITH THEM THAT THE PROBLEM DOES NOT OCCUR IN EVERY SAMPLE BUT IS MONITORED AND EVERY ABNORMALITY IS DOCUMENTED. IF THE ISSUE OCCURS AGAIN, THEN AN APPLICATION SPECIALIST WILL BE REQUIRED TO ASSIST INSTEAD AS THE INSTRUMENT IS FINE. THE INSTRUMENT WAS RUNNING AS EXPECTED AND NO PARTS WERE REPLACED FOR FURTHER EVALUATION. ALTHOUGH THIS COMPLAINT INVOLVES ERRONEOUS RESULTS, NO RESULTS WERE REPORTED TO THE CLINICIAN, NOR WAS A PATIENT HARMED OR INJURED FROM DIAGNOSIS. THE SAFETY RISK OF THIS HAZARD HAS BEEN IDENTIFIED TO BE WITHIN THE ACCEPTABLE LEVEL. ¿ CONCLUSION: BASED ON THE INVESTIGATION, THE POTENTIAL CAUSE COULD NOT BE DETERMINED. AN FSE TROUBLESHOOTED AND TESTED THE INSTRUMENT, AND FOUND THEY COULD NOT DUPLICATE THE ISSUE. HOWEVER, THE CUSTOMER WILL CONTACT AN APPLICATION SPECIALIST IF THE ISSUE HAPPENS AGAIN AS THE INSTRUMENT WAS PERFORMING AS EXPECTED. COMPLAINT WAS CONFIRMED BECAUSE THE FSE CONSULTED WITH THE CUSTOMER AND VERIFIED WITH THEM THAT THE PROBLEM DOES NOT OCCUR IN EVERY SAMPLE BUT IS MONITORED AND EVERY ABNORMALITY IS DOCUMENTED. NO ERRONEOUS RESULTS WERE REPORTED TO CLINICIANS AND NO PATIENTS WERE HARMED DUE TO THIS ISSUE. 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 THERE WAS NO IMPACT TO CUSTOMER AND PATIENT HEALTH OR SAFETY. ¿ SUPPORTING DOCUMENT:
IT WAS REPORTED THAT WHILE USING THE BD FACSLYRIC¿ THAT THERE WAS ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN OUR PARTICULAR CASE, THE ARTIFACT CAN ONLY BE SEEN BY LOOKING AT THE LYMPHOCYTES AS THE TARGET POPULATION. THIS IS WHERE INCORRECT CD13/CD33 EXPRESSION OCCURS (CD13= PE-CY7, CD33= BV786). SINCE WE DO NOT HAVE OUR PRIMARY FOCUS ON THE LYMPHOCYTE POPULATION, NO INCORRECT RESULTS WERE REPORTED AND NO PATIENT WAS TREATED DIFFERENTLY BECAUSE OF THE ARTIFACTS. THE FIGURE SHOWS THE TWO FALSE POSITIVE "CLOUDS" IN THE CD33-CD13 PLOT THE PROBLEM WITH THE MEASUREMENTS WAS PARTICULARLY NOTICEABLE WITH THE COMPENSATION PE-CY7 AGAINST PERCPCY5.5, WHICH IS WHY I RECOMMENDED A NEW CREATE LW/LNW. WITH THE CREATE THERE WERE PROBABLY ALSO ERRORS IN THE INSTRUMENT, SHEATH FILTER WAS CHANGED AT THE BEGINNING OF THE YEAR. TUE (B)(6) 12:04:30 UTC - PATIENT FIELDS UPDATED: HAZARD, INJURY OR ERRONEOUS RESULTS? NO. HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS.
IT WAS REPORTED THAT WHILE USING THE BD FACSLYRIC¿ THAT THERE WAS ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN OUR PARTICULAR CASE, THE ARTIFACT CAN ONLY BE SEEN BY LOOKING AT THE LYMPHOCYTES AS THE TARGET POPULATION. THIS IS WHERE INCORRECT CD13/CD33 EXPRESSION OCCURS (CD13= PE-CY7, CD33= BV786). SINCE WE DO NOT HAVE OUR PRIMARY FOCUS ON THE LYMPHOCYTE POPULATION, NO INCORRECT RESULTS WERE REPORTED AND NO PATIENT WAS TREATED DIFFERENTLY BECAUSE OF THE ARTIFACTS. THE FIGURE SHOWS THE TWO FALSE POSITIVE "CLOUDS" IN THE CD33-CD13 PLOT THE PROBLEM WITH THE MEASUREMENTS WAS PARTICULARLY NOTICEABLE WITH THE COMPENSATION PE-CY7 AGAINST PERCPCY5.5, WHICH IS WHY I RECOMMENDED A NEW CREATE LW/LNW. WITH THE CREATE THERE WERE PROBABLY ALSO ERRORS IN THE INSTRUMENT, SHEATH FILTER WAS CHANGED AT THE BEGINNING OF THE YEAR. TUE MAR 14 12:04:30 UTC 2023 - PATIENT FIELDS UPDATED: HAZARD, INJURY OR ERRONEOUS RESULTS? NO HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1730099 | BD FACSLYRIC¿ | NA | OYE | BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |