BD FACSLYRIC¿
Report
- Report Number
- 2916837-2022-00006
- Event Type
- Malfunction
- Date Received
- January 20, 2022
- Date of Event
- September 15, 2021
- Report Date
- March 2, 2022
- Manufacturer
- BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
- Product Code
- OYE
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
H6: INVESTIGATION SUMMARY SCOPE OF ISSUE: THE SCOPE OF ISSUE IS ONLY LIMITED TO FACSLYRIC 3L12C INSTRUMENT CEIVD, PART # 663029, SERIAL # (B)(6). PROBLEM STATEMENT: CUSTOMER REPORTED A COMPLAINT REGARDING THE INSTRUMENT PRODUCING ERRONEOUS RESULTS. MANUFACTURING DEFECT TREND: THERE ARE 0 QNS (QUALITY NOTIFICATIONS) RELATED TO THE REPORTED ISSUE. DATE RANGE FROM 13JAN2021 TO DATE 13JAN2022. COMPLAINT TREND: THERE ARE 5 COMPLAINTS RELATED TO THE ISSUE OF ERRONEOUS RESULTS; DATE RANGE FROM 13JAN2021 TO DATE 13JAN2022. MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW: DHR PART #663029 SERIAL # R663029000343, FILE # 663029-663029-R663029000343-107444293-21, WAS REVIEWED. THE INSTRUMENT MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. INVESTIGATION RESULT / ANALYSIS: THE INVESTIGATION WAS PERFORMED AND BASED ON THE REVIEW OF THE COMPLAINT TREND, DEFECT TREND, DHR, RISK ANALYSIS AND SERVICEMAX, THE ROOT CAUSE OF THE ERRONEOUS RESULTS COULD NOT BE DETERMINED. THE CUSTOMER HAD INITIALLY REPORTED THAT FOLLOWING THE CST BEAD LOT TRANSFER (LOT 1111357 TO LOT 1215683), THE CELL POPULATIONS WERE NOT WHAT WAS EXPECTED. THE RESULTS IN CHANNELS V450, FITC, AND V500C WERE ALSO UNEXPECTED. THE CUSTOMER HAD BEEN IN CONTACT WITH AN APPLICATION SPECIALIST, BUT THE APPLICATION SPECIALIST WAS ALSO UNABLE TO FIND A CAUSE OF THE ISSUE. NO PARTS WERE REQUESTED FOR EVALUATION AS THERE WERE NO PARTS REPLACED. AFTER THE CONSULTATION WITH THE APPLICATION SPECIALIST, THE CUSTOMER REPORTED THAT THE INSTRUMENT WAS FUNCTIONING AS EXPECTED. WHILE NO CAUSE COULD BE FOUND WITHIN THE WORK ORDER, TASK 4286006 ¿ ¿WFI-SAFETY ALIGNMENT¿ SUGGESTS THAT THE ERROR WAS DUE TO AN OPERATOR ERROR. ALTHOUGH THE UNEXPECTED RESULTS WERE FROM PATIENT SAMPLES FOR CLINICAL USE, NO PATIENT WAS TREATED NOR HARMED FROM INCORRECT RESULTS. THE RESULTS WERE CAPTURED PRIOR TO ANY DIAGNOSIS DECISION AND WAS REPORTED TO BD AS NOT EXPECTED. THERE WAS NO DELAY IN PATIENT TREATMENT DUE TO ANY UNEXPECTED RESULTS. PROPER DAILY AND MONTHLY CLEANING PROCEDURES CAN BE FOUND UNDER ¿MAINTENANCE¿ IN THE USER GUIDE; BD FACSLYRIC¿ CLINICAL SYSTEM INSTRUCTIONS FOR USE, #23-19938-02 REV. 1/VERS. A. THE SAFETY RISK IS LIMITED, S2, AND THERE WAS NO IMPACT TO PATIENT HEALTH OR SAFETY. SERVICE MAX REVIEW: REVIEW OF RELATED WORK ORDER #: 02287971, CASE # 01565610 INSTALL DATE: 13SEP2021 DEFECTIVE PART NUMBER: N/A WORK ORDER NOTES: O SUBJECT / REPORTED: 663029 - FACSLYRIC - UNEXPECTED RESULT AFTER CST BEAD LOT TRANSFER O PROBLEM DESCRIPTION: CUSTOMER REPORTS THAT SINCE THE CST BEAD LOT TRANSFER WAS PERFORMED (FROM LOT 1111357 TO LOT 1215683) THE CELL POPULATIONS ARE NOT LOOKING THE SAME IN THE PLOTS. IN PARTICULAR THE ISSUE AFFECTS CHANNELS V450, FITC, AND V500C (SEE IMAGES ATTACHED). CUSTOMER HAS BEEN IN CONTACT WITH AN APP SPECIALIST WHO WAS NOT ABLE TO FIND THE CAUSE OF THE PROBLEM. O WORK PERFORMED: ISSUE SOLVED BY APPLICATION SPECIALIST O CAUSE: UNKNOWN O SOLUTION: THE INSTRUMENT IS WORKING WITHIN SPECS RETURNED SAMPLE EVALUATION: A RETURN SAMPLE WAS NOT REQUESTED BECAUSE NO PARTS WERE REPLACED. RISK ANALYSIS: RISK MANAGEMENT FILE PART # 10000063058RA, REV. 06/VERS. Z, BD FACSLYRIC SYSTEM RISK ANALYSIS WAS REVIEWED. NO NEW HAZARDS HAVE BEEN IDENTIFIED AND THE CURRENT MITIGATIONS ARE SUFFICIENT. HAZARD(S) IDENTIFIED? ¿YES ¿NO O AZURE ID: 89263 O ID: LIBIVD-RA-334 3.1.61 O REG STATUS: IVD; RUO O HAZARD: INCORRECT MEASUREMENT LEADING TO WRONG INTERPRETATION OF DATA O CAUSE: FCBEADS USED TO CREATE USER DEFINED REFERENCE SETTINGS (ASSAY BRIGHTNESS + SPILLOVER VALUES) ARE DECAYED DUE TO NOT BEING HANDLED IN ACCORDANCE WITH PACKAGE INSERT (TEMP, HUMIDITY, DILUENT, LIGHT EXPOSURE) O HARMFUL EFFECTS: WRONG BRIGHTNESS SETUP AND/OR WRONG COMPENSATION LEADS TO DELAY/RE-RUN OF FLOW RESULTS LEADING O RISK CONTROL: PACKAGE INSERT ON BEAD HANDLING; DATA SHEET-RUO BEAD HANDLING (RUO). IVD ASSAYS AGE OF BLOOD AND AGE OF STAIN SPECIFICATIONS SUPPORT A SAME DAY RE-RUN O REQ LINK (AZURE ID): 92011 FS11-RGT-286 PACKAGE INSERT, IVD FCB KITS O IMPLEMENTATION VERIFICATION: LIBIVD-SE-15-51IR O EFFECTIVENESS VERIFICATION: LIBIVD-SE-15-51IR O PROBABILITY: 2 O SEVERITY: 2 O RISK INDEX: 4 O RESIDUAL RISK EVALUATION: A O NEW HAZARDS: NONE O AZURE ID: 89264 O ID: LIBIVD-RA-335 3.1.62 O REG STATUS: IVD; RUO O HAZARD: INCORRECT MEASUREMENT LEADING TO WRONG INTERPRETATION OF DATA O CAUSE: CORRUPTED CS&T BEAD INFORMATION FROM INPUT (ISSUES WITH WEB DOWNLOAD, TRANSFER OF FILE FROM OTHER COMPUTER, BARCODES) O HARMFUL EFFECTS: MAY LEAD TO DELAYED RESULTS IF THE DAILY QC DOES NOT INDICATE A PASS O RISK CONTROL: IF CHECKSUM ON BEAD LOT INFORMATION FAILED, BEAD LOT CANNOT BE ENTERED. O REQ LINK (AZURE ID): 91681 FS11-SQC-1762 CYTOMETER PERFORMANCE QC -CRITERIA. 91918 FS11-RGT-293 BEAD LOT INFO-CHECKSUM O IMPLEMENTATION VERIFICATION: LIBIVD-15-04P O EFFECTIVENESS VERIFICATION: LIBIVD-15-04F O PROBABILITY: 1 O SEVERITY: 2 O RISK INDEX: 2 O RESIDUAL RISK EVALUATION: A O NEW HAZARDS: NONE O AZURE ID: 89266 O ID: LIBIVD-RA-337 3.1.64 O REG STATUS: IVD; RUO O HAZARD: INCORRECT MEASUREMENT LEADING TO WRONG INTERPRETATION OF DATA O CAUSE: INCORRECT INFORMATION IS GENERATED IN THE BEAD LOT FILE. O HARMFUL EFFECTS: MAY LEAD TO DELAYED RESULTS IF THE DAILY QC DOES NOT INDICATE A PASS O RISK CONTROL: REAGENT OPS QC WORK INSTRUCTION TO VERIFY ABD VALUES AND SOF. PASS/FAIL CRITERIA FOR CS&T. PROCESS CONTROLS WILL ASSIST IN DETECTING ERRORS. O REQ LINK (AZURE ID): 91681 FS11-SQC-1762 CYTOMETER PERFORMANCE QC -CRITERIA. 91918 FS11-RGT-293 BEAD LOT INFO-CHECKSUM O IMPLEMENTATION VERIFICATION: LIBIVD-SE-15-51IR, LIBIVD-SE-15-84AR O EFFECTIVENESS VERIFICATION: LIBIVD-SE-15-51IR, LIBIVD-SE-15-84AR O PROBABILITY: 1 O SEVERITY: 2 O RISK INDEX: 2 O RESIDUAL RISK EVALUATION: A O NEW HAZARDS: NONE MITIGATION(S) SUFFICIENT ¿YES ¿NO ROOT CAUSE: BASED ON THE INVESTIGATION RESULTS THE ROOT CAUSE OF THE ERRONEOUS RESULTS COULD NOT BE DETERMINED. CONCLUSION: BASED ON THE INVESTIGATION RESULTS THE ROOT CAUSE OF THE ERRONEOUS RESULTS COULD NOT BE DETERMINED. THE CUSTOMER HAD REPORTED THAT THE CELL POPULATIONS IN SEVERAL CHANNELS WERE NOT WHAT WAS EXPECTED, AND THAT THEY WERE IN CONTACT WITH AN APPLICATION SPECIALIST. THE APPLICATION SPECIALIST WAS UNABLE TO FIND ANY ISSUES WITH THE INSTRUMENT. AFTER CONSULTATION WITH THE APPLICATION SPECIALIST, THE CUSTOMER HAS REPORTED THAT THE INSTRUMENT WAS WORKING WITHIN SPECIFICATIONS. NO ONE WAS HARMED OR INJURED, AND NO MEDICAL DIAGNOSIS WAS PERFORMED DUE TO ANY INCORRECT RESULTS. THE SAFETY RISK IS LIMITED, S2, AND THERE WAS NO IMPACT TO PATIENT HEALTH OR SAFETY. H3 OTHER TEXT : SEE H10
IT WAS REPORTED THAT BD FACSLYRIC¿ ACQUIRED ERRONEOUS RESULTS ON PATIENT SAMPLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTS THAT SINCE THE CST BEAD LOT TRANSFER WAS PERFORMED (FROM LOT 1111357 TO LOT 1215683) THE CELL POPULATIONS ARE NOT LOOKING THE SAME IN THE PLOTS. YES, ERRONEOUS RESULTS WERE OBTAINED ON PATIENTS SAMPLES, BUT THEY WERE NOT USED FOR DIAGNOSIS AND THERE WAS NO DELAY IN TREATMENT. NO HARM TO PATIENTS. IT WAS CAUSED BY AN OPERATOR¿S ERROR. "
IT WAS REPORTED THAT BD FACSLYRIC¿ ACQUIRED ERRONEOUS RESULTS ON PATIENT SAMPLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTS THAT SINCE THE CST BEAD LOT TRANSFER WAS PERFORMED (FROM LOT 1111357 TO LOT 1215683) THE CELL POPULATIONS ARE NOT LOOKING THE SAME IN THE PLOTS. YES, ERRONEOUS RESULTS WERE OBTAINED ON PATIENTS SAMPLES, BUT THEY WERE NOT USED FOR DIAGNOSIS AND THERE WAS NO DELAY IN TREATMENT. NO HARM TO PATIENTS. IT WAS CAUSED BY AN OPERATOR¿S ERROR. "
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1760808 | BD FACSLYRIC¿ | NA | OYE | BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |